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U.S. Department of Health and Human Services

Safety

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Enforcement Report for April 11, 2012

 

April 11, 2012                                                                                         12-15
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I
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PRODUCT
Dehydrated Kibbled Mushrooms, 4-6 mm pieces; 25 lbs. polylined boxes; item #1601. Recall # F-0955-2012
CODE
Lot W4111
RECALLING FIRM/MANUFACTURER
Recalling Firm: Quick Dry Foods, Usa Inc., Waukegan, IL, by telephone on March 13, 2012 and e-mails on March 14, 2012 and March 15, 2012.
Manufacturer: Winfield (Linyi) Food Co., Ltd., Shandong Province, China, Feixian. FDA Initiated recall is ongoing.
China.
REASON
The dehydrated kibbled mushrooms were found to be contaminated with Salmonella bacteria.
VOLUME OF PRODUCT IN COMMERCE
113 cases
DISTRIBUTION
IL, KS, LA, MA, TX, UT, WI, and Canada
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PRODUCT
Fresh Jalapeno Peppers, a) Full Bushel, Item # 620JAL40; b) Bushel, Item # 620JAL; c) 1 lb BC, Item # 620J1; d) 2# 5-GUYS BC, Item # 620J55GUYS; e) 2# BC Item # 620JAL2; f) 5# BC Item # 620JAL5; g) 10 lb BC Item # 620JAL10; h) 20 lb BC Item # 620JAL20 Corrugated cartons. Recall 3 F-1032-2012
CODE
a) Lot # 280104C07;
b) Lot #, 2072B010;
c) Lot #s: 1976536, 1976553, 1976852, 1976863, 1977272, 1977376, 1977604, 1977643, 1978218, 1978234, 1978379, 1978640 & 1980151;
d) Lot #'s 1976393, 1976549, 1976786, 1977220, 1977310, 1977514, 1977845, 1977913, 1978122, 1978574, 1979034 & 1980217;
e) Lot # 1976393, 1976395, 1976551, 1976786, 1977310, 1977845, 1977911, 1977913, 1978122, 1978125, 1978217, 1978565, 1978574, 1978930, 1979034 & 1979059;
f) Lot #s 1976705, 1977256 & 1978136;
g) Lot #s, 1976412, 1976413, 1976414, 1976416, 1976502, 1976508, 1976509, 1976534, 1976712, 1976713, 1976714, 1976716, 1976717, 1976765, 1976774, 1976857, 1976913, 1977086, 1977087, 1977233, 1977234, 1977236, 1977289, 1977320, 1977329, 1977352, 1977434, 1977455, 1977520, 1977522, 1977523, 1977524, 1977616, 1977743, 1977863, 1977865, 1977866, 1977906, 1978070, 1978077, 1978145, 1978146, 1978152, 1978153, 1978178, 1978472, 1978473, 1978479, 1978480, 1978481, 1978483, 1978559, 1978563, 1978618, 1978831, 1978832, 1978833, 1978896, 1978930, 1978949, 1978952, 1978954, 1978958, 1978959, 1979025, 1979030 & 1979211; h) Lot # 1976566
RECALLING FIRM/MANUFACTURER
Castellini Company LLC, Wilder, KY, by telephone on March 20, 2012, by letters on March 23, 2012 and by press release on March 29, 2012. Ohio Initiated recall is ongoing.
REASON
A random sample of the product was tested and found positive for salmonella.
VOLUME OF PRODUCT IN COMMERCE
148 cases
DISTRIBUTION
IL, IN, KY, MI, OH, PA, SC, TN, VA & WV
___________________________________
PRODUCT
FA691001 Pre-mix TE37-2/Dry, 50 LB kraft bags, labeled in part ***For Manufacturing and Professional Use. Made in U.S.A. Recall # F-1033-2012
CODE
Lot 51118227
RECALLING FIRM/MANUFACTURER
McCormick & Company, Inc - USIG HQ, Hunt Valley, MD, by letter and telephone on March 16, 2012. Firm initiated recall is ongoing.
REASON
Industrial food product was produced with ingredients which had been recalled due to potential Salmonella contamination.
VOLUME OF PRODUCT IN COMMERCE
38- 50 lb bags
DISTRIBUTION
WI
___________________________________
PRODUCT
1) Queso Fresco sold under the following brand names: 1) El Ranchero Queso Fresco Fresh Cheese, 14 oz. plastic clamshell UPC 88052230013, Net Weight 14 Oz (397 g) Serving Size 1 oz (30 g); 2) Los Corrales Queso Fresco En Hoja De Platano Fresh Cheese and Banana Leaf Net Weight 14 oz. (397 g) packed in a plastic clamshell UPC 880522300037 Serving Size 1 oz. (30 g). Recall # F-1034-2012
 
2) El Ranchero Queso Hebra Queso Oaxaca String Cheese, Net Weight 14 Oz (396.9 g). UPC 880522300068 14 oz. shrink wrap Serving Size 1 oz (30g) n 14 oz. shrink wrap Serving Size 1 oz (30g) El Ranchero Queso Hebra Queso Oaxaca String Cheese, Net Weight 14 Oz (396.9 g). UPC 88522300051 Serving Size 1 oz. (30 g); 10 lb. plastic loose wrap. Recall # F-1035-2012
CODE
1) Sell by dates 02/23/2012-03/16/2012; 2) sell by dates 2/23/12-3/16/12;
2) Sell by dates 2/23/12-3/16/12
RECALLING FIRM/MANUFACTURER
El Ranchero Del Sur, LLC, South River, NJ, by press release on March 16, 2012 and letters on March 19, 2012. New Jersey Initiated recall is ongoing.
REASON
Los Corrales Queso Fresco en Hoja De Platano may be contaminated with Listeria monocytogenes resulting in the recall of two additional products.
VOLUME OF PRODUCT IN COMMERCE
55,172 lbs
DISTRIBUTION
NJ, PA
___________________________________
PRODUCT
Raw Jalapeno peppers are packed in a white cardboard box. White box contains red print and is labeled :***KEEP REFRIGERATED PERISHABLE Handle With Care***Grown & Packed by: South Florida Produce, 1 1/9 BU. PRODUCE OF U.S.A.*** This label is only attached to one (1) cardboard box on one pallet (~50 boxes per pallet). Recall # F-1052-2012
CODE
Pallet Numbers: J000010995, J000010996, J000010997, J000010998, J000010999, J000011000, J000020135, J000020136, J000020137, J000020138, J000020139, and J000030053
RECALLING FIRM/MANUFACTURER
South Florida Produce, Inc., Boynton Beach, FL, by telephone and follow-up letter on March 27, 2012. Firm Initiated recall is ongoing.
REASON
A sample of jalapeno peppers tested positive for salmonella.
VOLUME OF PRODUCT IN COMMERCE
920 boxes
DISTRIBUTION
NC, FL, D.C., NJ, and Canada
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II
________________________________
PRODUCT
Sonoma Seafoods Atlantic Salmon Burger, Net Wt. 8 oz Vacuum Packed, Frozen. Recall # F-0968-2012
CODE
Use By Dates: 07/28/2012; 07/30/2012; 10/22/2012; 10/30/2012
RECALLING FIRM/MANUFACTURER
Recalling Firm: Slade Gorton & Company, Inc., Boston, MA, by e-mail on November 3, 2011.
Manufacturers: Clear Springs Foods, Inc., Buhl, ID;  
M.S. Intertrade East, Inc., Elgin, IL;
M.S. Intertrade Nevada, LLC, Sparks, NV. Firm initiated recall is ongoing.
REASON
Salmon Burger positive for Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
775 cases
DISTRIBUTION
CO, OR, TX, WA
___________________________________
PRODUCT
1) 15 Dias Limpia Intestinal, 15 Day Cleanse. The booklet in Spanish is labeled in parts: "***15 DIAS LIMPIEZA INTESTINAL (Limpieza del Colon) ***MIRGEN PHARMACEUTICAL***Para la limpieza del tracto digestivo La mayoria de las culturas antiguas creen en el poder de la digestion saludable para mantener a raya las enfermedades graves***15 DIAS LIMPIEZA INTESTINAL es un suplemento de formula avanzada, efectivo para mantener el colon saludable. Empieza a dar resultados entre 12 y 24 horas. Mejora la digestion, alivia diarreas y otros desordenes digestivos. Desintoxicacion de todo el cuerpo. Absorcion de nutrientes y vitaminas en su dieta para una mejor salud. Mejor estado de animo, energia, sueno y tono de la piel Mejor enfoque y funcion cerebral Perdida de peso***USO SUGERIDO Como un suplemento dietetico, este producto puede ser utilizado para uso ocasional o como parte de un programa de limpieza.***Para uso ocasional solamente, tomar una (1) a dos (2) capsulas cuando sea necesario. Como parte de una limpieza de 15 dias tome dos (2) capsulas al dia durante 15 dias. No repita el ciclo de limpieza por lo menos en 6 u 8 semanas. *** PRECAUCIONES: No exceder la dosis recomendada. Este producto contiene hojas de Zen( Senna Leaves y Cascara sagrada. No esta recomendado a mujeres embarazadas o lactantes ni a ninos meno-res de 18 anos de edad. No use este pro-ducto si tiene dolor abdominal, diarrea o deposicion blanda. No lo use por mas de una semana. No exceda la dosis diaria recomendada. Sangrado rectal y/o falta de evacuacion intestinal despues del uso de una formula laxante puede ser una indicacion de una condicion mas seria.*** PRECAUCIONES: (Continuacion) Si esto ocurre o si tiene una condicion medica conocida y esta tomando medicinas debe consultar a un medico antes de usar este o cualquier otro suplemento diettico. Este producto es fabricado y envasado en una instalacion que tambien puede procesar leche, soya, trigo, huevos, mani, pescado y crustaceos. Esta declaracion no ha sido evaluada por la Administracion de Drogas y Alimentos- FDA. Este producto no tiene como finalidad diagnosticar, tratar, curar o prevenir ninguna enfermedad***". ENGLISH TRANSLATION OF THE SPANISH BOOKLET: "***15-Day Intestinal Cleanse (Cleaning of the Colon) For the cleaning of the digestive tract Most ancient cultures believe in the power of a healthy digestion for keeping serious diseases at bay. 15-Day Intestinal Cleanse is an advanced supplement formula to maintain a healthy colon. Begins to give results in 12 to 24 hours***It improves digestion, relieves diarrhea and other digestive disorders. Detoxification of the body. Absorption of nutrients and vitamins in your diet for better health. Better mood, energy, sleep and skin tone. Best approach and brain function. Weight loss*** SUGGESTED USE: As a dietary supplement, this product can be used occasionally or as part of a cleaning program. For occasional use only, take one (1) or two (2) capsules as needed. As part of a 15-day cleanse, take two (2) capsules daily for 15 days. Do not repeat the cleaning cycle for at least 6 to 8 weeks*** CAUTION: Do not exceed recommended dose. This products contains Senna leaves and Cascara sagrada. This products is not recommended for pregnant or nursing women or children under the age of 18 years. Do not use this product if you have abdominal pain, diarrhea or soft stool. Do not use for more than one week. Do not exceed the recommended daily dose. Rectal bleeding and/or lack of bowel evacuation after using a laxative formula may be an indication of a more serious condition. If this happens, or if you have a known medical condition and are taking medication, consult a physician before using this or any other dietary supplement.*** This product is manufactured and packaged in a facility that can also process milk, soy, wheat, eggs, peanuts, fish and crustaceans.*** These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, prevent or cure any disease***". Recall # F-0988-2012;
 
2) Aceite de Linaza, Flax seed Oil,1000mg. The Spanish booklet is labeled in parts: "***ACEITE DE LINAZA (Flaxseed Oil)***Promueve una salud ?ptima y bienestar en general***MIRGEN PHARMACEUTICAL***El aceite de linaza es una muy buena fuente de omega-3 (ALA), omega-6(AO) y omega-9 que son ?cidos grasos esenciales necesarios para promover una salud ?ptima y bienestar en general. Se consideran "esenciales" porque el cuerpo no los produce por su cuenta***Esto significa que deben ser consumidos ya sea por la comida o suplementos nutricionales, como el aceite de linaza*** Estudios muestran que los ?cidos grasos omega-3,6 y 9 juegan un papel decisivo en: En regular la degradaci?n del colesterol y los triglic?ridos; Presi?n arterial; Producci?n de energ?a; Membranas celulares de todo el cuerpo; Actividad del sistema inmune y del sistema nervioso central; Prevenci?n del c?ncer de mama, pr?stata y colon;? Salud cardiovascular; Estado de ?nimo; Alergias, asma y varios trastornos cut?neos*** Metabolismo hormonal de las mujeres en etapa posmenop?usica; ***USO SUGERIDO Como suplemento diet?tico, tomar una (1) c?psula de gel con cada comida. ***PRECAUCIONES: No exceder la dosis recomendada. Mujeres embarazadas o lactantes, ni?os menores de 18 a?os de edad***PRECAUCIONES: (Continuaci?n) personas con una condici?n m?dica conocida deben consultar a su m?dico antes de usar este o cualquier otro suplemento diet?tico. Este producto es fabricado y envasado en una instalaci?n que tambi?n puede procesar leche, soya, trigo, huevos, man?, pescado y crust?ceos.***Esta declaraci?n no ha sido evaluada por la Administraci?n de Drogas y Alimentos- FDA. Este producto no tiene como finalidad diagnosticar, tratar, curar o prevenir ninguna enfermedad***". The English translation provided by the firm: "***ACEITE DE LINAZA (Flaxseed Oil)***Promotes optimal health and general well-being***Flaxseed oil is a very good source of Omega-3 (ALA), Omega-6, (AO), and Omega-9 which are essential fatty acids necessary to promote optimal health and general well-being. They are deemed 'essential' because the body does not produce them on their own. This means that they must be consumed as a food or a nutritional supplement, such as flaxseed oil*** Studies have shown that Omega-3, 6 and 9 fatty acids play a decisive role in: Regulating the degradation of cholesterol and triglycerides Blood pressure Energy production Cell membranes though out the body Activity of the immune system and the central nervous system Breast cancer prevention Prostate and colon Cardiovascular health Mood Allergies, asthma, and several skin disorders Hormone metabolism of women in post menopause*** SUGGESTED USE: As a dietary supplement, take (1) capsule of gel with each meal*** CAUTION: Do not exceed the recommended dose. Pregnant and nursing women, children under 18 years of age, persons with a known medical condition should consult their physician before using this or any other dietary supplement*** This product is manufactured and packaged in a facility that can also process milk, soy, wheat, eggs, peanuts, fish and crustaceans.This statement has not been evaluated by the food - FDA and drug administration. This product is not intended to diagnose, treat, cure or prevent any disease***". Recall # F-0989-2012;
 
3) Animoplas, Mood support, Capsule, 2 mg Vitamine B1, 2. The SPANISH BOOKLET IS LABELED IN PARTS: "***ANIMOPLAS (Mood Control)***Es una formuarmula para el aumento natural del estado de animo***MIRGEN PHARMACEUTICAL*** Ayuda a: Mejorar el estado de animo Reducir el estrs y mejorar el sueno Contiene: SAM por sus beneficios en el bienestar emocional. MAE que ayuda con el estado de alerta y su influencia positiva en el animo*** GABA por sus propiedades relajantes y anti-ansiedad*** CONCENTRADO DE MANZANILLA para ayudar a reducir el estres y mejorar el sueno*** ASHWAGANDHA conocida por sus propiedades naturales sedantes. 5-HTP ayuda con el sueno y lucha contra la depresion*** VITAMINAS del complejo B como B-1, B-2, B-6, B-12 ayuda en la lucha contra el estres y la irritabilidad*** EL CALCIO Y EL MAGNESIO ayudan con los cambious de muhor y depresion y a calmar el cuerpo*** USO SUGERIDO: Como suplemento dietetico, tomar una (1) a dos (2) capsulas diarias o segun lo recomendado por un profesional de la salud*** PRECAUCIONES: No exceder la dosis recomendada. Evite conducir or manejar maquinaria pesada mientras lo consume. No esta recomendado a mujeres embarazadas o lactantes ni a ninos menores de 18 anos de edad. No debe ser usado por personas con una condicion medica conocida incluyendo enfermedades del higado, bipolares (maniacos) depresivos o cualquier*** PRECAUCIONES (Continuacion): Personas tomando medicamentos prescritos incluyendo antidepresivos o inhibidores MAO. Si tiene preguntas acerca de la conveniencia de tomar este producto, consulte a su medico ante de usarlo. Este producto es fabricado y envasado en una instalacion que tambien puede procesar leche, soya, trigo, huevos, mani, pescado y crustaceos*** Esta declaracion no ha sido evaluada por la Administracion de Drogas y Alimentos FDA. Este producto no tiene como finalidad diagnosticar, tratar, curar o prevenir ninguna enfermedad***". THE ENGLISH TRANSLATION PROVIDED BY THE FIRM: Animoplas (Mood Control) It is a formula to naturally increase your mood. It helps to*** Improve the mood*** Reduce stress and improve sleep*** Contains*** SAM for its benefits in emotional well-being*** MAE helping with alertness and its positive influence on mood*** GABA for its relaxing and anti-anxiety properties*** CONCENTRATED CHAMOMILE to help reduce stress and improve sleep*** ASHWAGANDHA known for their natural sedative properties*** 5-HTP helps with sleep and fight against depression*** VITAMINS B as B-1, B-2, B-6 and B-12 helps to fight against stress and irritability*** CALCIUM and MAGNESIUM help with depression and calm the body*** SUGGESTED USE: As a dietary supplement, take one (1) or two (2) capsules daily or as recommended by a health professional*** CAUTION: Do not exceed the recommended dose. Avoid driving or operating heavy machinery after you have consumed this product. It is not recommended for pregnant or nursing women or for children under 18 years of age or persons. It should not be used by people with a known medical condition including the liver disease, bipolar (maniacs), depression or any people taking medicines prescribed including antidepressants or MAO inhibitors. If you have questions about the advisability of taking this product, consult your doctor before use*** This product is manufactured and packaged in a facility that can also process milk, soy, wheat, eggs, peanuts, fish and crustaceans*** This statement has not been evaluated by the FDA - food and drug administration. This product is not intended to diagnose, treat, cure or prevent any disease***". Recall # F-0990-2012;
 
4) Azudrol, Blood sugar support 60's, Capsule, 50 mg THE SPANISH BOOKLET IS LABELED IN PARTS: "***AZUDROL (Blood Sugar Support)***MIRGEN PHARMACEUTICAL*** Ayuda a mantener los niveles normales de azucar en la sangre.*** Contiene cinco compuestos de las mejo-res fuentes naturales para promover la salud en general. Investigaciones cienti-ficas han concluido que muchos com-puestos naturales ayudan al cuerpo a mantener el azucar sanguinea en niveles normales. Cuando se combina con ejercicio los resultados son aun mejores.*** CONTIENE:*** Gymnema Silvestre, significa "Destructor de azucar ayuda a la glucosa a ser reabsorbida en la sangre.*** Hojas de Banaba, eficaz para reducir la glucosa en la sangre en personas que regularmente tienen azcar alta. Ayuda a perder peso si el azucar alta en la sangre lo ha llevado a la obesidad.*** Melon amargo, contiene compuestos que aumentan la actividad de la enzima AMPK que se activa por del ejercicio y que ayuda a mover la glucosa desde el flujo sanguineo a las celulas. Canela, disminuye la resistencia a la insulina.*** Cromo, ayuda a mejorar el control de azucar en la sangre y ayuda en la perdida de peso.*** USO SUGERIDO: Como suplemento dietetico, tomar una (1) capsula antes de cada comida. No tomar mas de tres (3) capsulas al dia.*** PRECAUCIONES: No exceder la dosis recomendada. Este producto no esta recomendado a mujeres embarazadas o lactantes ni a ninos menores de 18 anos de edad o personas con una condicion medica conocida incluyendo desordenes cardiovasculares, hipotension (presion sanguinea baja)*** PRECAUCIONES: (Continuacion)*** si esta tomando cualquier medica-mento prescrito incluyendo para la presion alta y tiene preguntas acerca de la conveniencia de tomar este producto, consulte su medico antes de usarlo.*** Este producto es fabricado y envasado en una instalacion que tambien puede procesar leche, soya, trigo, huevos, mani, pescado y crustaceos.*** Esta declaracion no ha sido evaluada por la Administracion de Drogas y Alimentos- FDA. Este producto no tiene como finalidad diagnosticar, tratar, curar o prevenir ninguna enfermedad***". ENGLISH TRANSLATION PROVIDED BY THE FIRM: "***Azudrol (Blood Sugar Suport)*** It helps to maintain normal levels of sugar in the blood.*** It is composed of the best natural sources to promote general health. Scientific research has concluded that many natural compounds help the body maintain blood sugar at normal levels. When combined with exercise, the results are even better.*** Contains: Gymnema Silvestre, which means "sugar destroyer" which aids in the absorption in the blood glucose.*** Banaba leaf is effective for reducing the blood glucose in people who regularly have high blood sugar. It helps to lose weight if high blood sugar has led to obesity.*** Bitter melon contains compounds that increase the activity of the enzyme AMPK that is activated by the exercise that helps move glucose from the bloodstream to the cells.*** Cinnamon decreases insulin resistance.*** Chrome helps improve control of sugar in the blood and aid in weight loss.*** SUGGESTED USE: As a dietary supplement, take (1) capsule before each meal. Do not take more than three (3) capsules per day.*** CAUTION: Do not exceed the recommended dose. This product is not recommended for pregnant or nursing women or children under 18 years of age or people with a known medical condition such as cardiovascular disorders, hypertension (low blood pressure). If you are taking any prescription medication for high blood pressure and have questions about taking this product, consult with your doctor before using it.*** This product is manufactured and packaged in a facility which may also process milk, soy, wheat, egg, peanuts, fish and crustacean shellfish.*** These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, prevent or cure any disease***". Recall # F-0991-2012;
 
5) El Cachondo, Horny Goat Weed, Capsule, 1000 mg. Each bottle contains 60 capsules. THE SPANISH BOOKLET IS LABELED IN PARTS: "***EL CACHONDO FORMULA (Horny Goat Weed)***MIRGEN PHARMACEUTICAL*** Suplemento de hierbas naturales que ayuda a fortalecer la vitalidad sexual masculina y a aliviar el malestar de las mujeres en la edad mediana*** Combina un potente extracto estandari-zado de esta hierba antigua Hierba de la Cabra Arrecha (Horny Goat Weed) que es un estimulante sexual y una ayuda para aliviar los sIntomas menopAusicos, con hierba Maca, el energizador de*** AmErica del Sur, ademAs de Mucuna y otras hierbas conocidas por aumentar la testosterona y el libido, mejorar la efi-ciencia energEtica y aumentar el estado de Animo.*** El Cachondo te da todo lo que esperas de una pIldora de realce sexual, sin los efectos secundarios. Es un substituto seguro, legal y barato a las pIldoras como Viagra y Cialis. Es economica, y tampoco requiere prescripcion medica. Los elementos naturales en esta pildora aseguran alcanzar el placer y la alegria maxima de una manera natural y segura*** USO SUGERIDO: Como suplemento dietetico, tomar 2 capsulas una hora antes de actividad fisica. No tomar mas de 2 capsulas al dia.*** PRECAUCIONES: No exceder la dosis recomendada. Este producto no esta recomendado a mujeres embarazadas o lactantes ni a ninos menores de 18 anos de edad o personas tomando medica-mentos recetados. Descontinue inmediatamente su uso si le causa nauseas, insomnio o nerviosismo. No tome este producto si tiene una condicion medica conocida como hipertension arterial. diabetes,*** PRECAUCIONES (Continuacion): trastornos cardiovascular, enfer- medades del corazon, hipertiroidismo, o estan tomando medicamentos antide-presivos. Si tiene preguntas acerca de la conveniencia de tomar este producto, consulte su medico antes de usarlo. Este producto es fabricado y envasado en una instalacion que tambien puede procesar leche, soya, trigo, huevos, mani, pescado y crustaceos. Esta declaracion no ha sido evaluada por la Administracion de Drogas y Alimentos- FDA. Este producto no tiene como finalidad diagnosticar, tratar, curar o prevenir ninguna enfermedad***". THE ENGLISH TRANSLATION PROVIDED BY THE FIRM: "***El Cachondo Formula (Horny Goat Weed)***Natural herbal supplement that helps strengthen male sexual vitality and ease the discomfort of middle-aged women.*** Combines a powerful standardized extract of the ancient herb Arrecha goat grass (Horny Goat Weed) found in South America which is a sexual stimulant and aid in the relief of menopausal symptoms. In addition, Mucuna and other well know herbs increase testosterone and libido, improve energy efficiency and enhance mood.*** El Cachondo gives you everything you expect from a pill for sexual enhancement without side effects. It is a safe, legal and cheap substitute to pills such as Viagra and Cialis. It is economic, and requires no prescription. Natural elements in this pill ensure you will achieve pleasure and joy in a safe and natural way.*** SUGGESTED USE: As a dietary supplement, take 2 capsules one hour prior to physical activity. Do not take more than 2 capsules per day.*** CAUTION: Do not exceed the recommended dose. This product is not recommended for pregnant or nursing women or children under 18 years of age or persons taking prescription medication. Discontinue immediately if you experience nausea, insomnia and nervousness. Do not take this product if you have a known medical condition such as hypertension, diabetes, cardiovascular or heart disease, hyperthyroidism, of if you are taking anti-depressant drugs. If you have questions about taking this drug, consult with your doctor before using this or any dietary supplement.*** This product is manufactured and packaged in a facility which may also process milk, soy, wheat, egg, peanuts, fish and crustacean shellfish.*** These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, prevent or cure any disease". Recall # F-0992-2012;
 
6) Canafin, Turn Gray away, Coated Tablet, 10 mg. Each bottle contains 30 tablets. THE SPANISH BOOKLET IS LABELED IN PARTS: "***CANAFIN (Formula avanzada para el cabello)***Elimina las canas y promueve el color natural del cabello de una manera sana y natural sin quImicos ni tintes ademAs de evitar la caIda del cabello.*** CANAFIN es una nueva y eficaz formula que ayuda a recuperar el color original del cabello, centrada en "la catalasa," una enzima producida naturalmente por el cuerpo que evita que nuestro cabello se vuelva gris con la edad.*** CANAFIN es el primer producto de este tipo que ofrece catalasa junto con hierbas tradicionales, vitaminas y minerales que se cree son beneficiosas en promover el color natural del cabello y la salud.*** CANAFIN tambien contiene un alto nivel de Extracto de Saw Palmetto. Un estudio publicado en 1984 demostro que Saw Pametto ayuda a limitar la produccion de ciertas enzimas responsables de la perdida del cabello tanto en hombres como en mujeres. Como se toma por via oral es posible que requiera hasta 8 semanas de tratamiento para ver algunos resultadosdebido a los ciclos de crecimiento del pelo.*** Desde las primeras pruebas y estudios los usuarios aseguran haber obtenido una gran diferencia en el estado de su cabello.*** MIRGEN trabaja constantemente para proveer productos que te ayuden a verte ms joven y a sentirte mejor.*** USO SUGERIDO*** Como suplemento diettico, tomar dos (2) capsulas al dia con comida.*** PRECAUCIONES: No exceder la dosis recomendada. Mujeres embarazadas o en lactancia, ninos menores de 18 anos, y personas con una condicion medica conocida deben consultar a un medica cantes de usar este o cualquier otro suplemento dietetico. Este producto es fabricado y envasado en una instalcion que tambien puede procesar leche, soya, trigo, huevos, mani, pescado y crustaceos.*** Esta declarcion no has sido evaluada por la Administraciode Drogas y Alimento-FDA. Este producto no tiene como finalidad diagnossticar, trator, curar o prevenir ninguna enfermedad.***". THE ENGLISH TRANSLATION PROVIDED BY THE FIRM: Canafin (Advanced Hair Formula) Eliminates the gray and promotes the natural color of the hair in a healthy and natural way without chemicals or dyes, as well as prevents hair loss.*** Canafin is a new and effective formula that helps to recover the original hair color using "catalase," an enzyme produced naturally by the body that prevents our hair from turning gray with age. Canafin is the first product of this type offered with catalase along with traditional herbs, vitamins and minerals that are believed to be beneficial in promoting natural hair color and health. Canafin also contains a high level of Saw Palmetto extract. A study published in 1984 showed that Saw Palmetto helps to limit the production of certain enzymes responsible for hair loss in men as well as women. As it is taken by mouth, it is possible to require up to 8 weeks of treatment before seeing results based on hair growth cycles. Since the first tests and studies, users claim to have obtained a great difference in the state of their hair. Mirgen is constantly working to provide products that will help you to feel younger and better.*** SUGGESTED USE: As a dietary supplement, take two (2) capsules daily with food.*** CAUTION: Do not exceed the recommended dose. Pregnant or lactating women, children under 18 years of age, and people with a known medical condition should consult a doctor before using this or any dietary supplement. This product is manufactured and packaged in a facility that can also process milk, soy, wheat, eggs, peanuts, fish and crustaceans.*** These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, prevent or cure any disease***". Recall # F-0993-2012;
 
7) Ceretal, Mind matrix, Capsule, 50 mg. Each bottle contains 30 capsules. THE SPANISH BOOKLET IS LABELED IN PARTS: "***CERETAL (Activador del metabolismo Cerebral)***MIRGEN PHARMACEUTICAL***Incrementa la Agilidad Mental, Concentracion y Memoria.*** CERETAL es una formula completa para el cerebro, 100% natural. Contiene los mas eficaces y estudiados nutrientes y hierbas que brindan una ayuda optima para la mente, proporcionando agilidad mental, enfoque, mayor claridad, concentracin y lucidez. Contiene 8 ingredientes altamente eficaces, que apoyan la capacidad neuronal de nuestro cerebro, aportando nutrientes que el cerebro sano necesita para funcionar al mximo rendimiento. " Mejora la memoria y el recuerdo " Restaura la agilidad del pensamiento " Aumenta la claridad " Elimina la fatiga mental " Mejora el enfoque y el estado de animo " Aumenta la atencin y la concentracion*** USO SUGERIDO: Como suplemento dietetico, tomar una (1) capsula al dia. No tomar mas de 2 capsulas al dia.*** PRECAUCIONES: La Hierba St.John Wort puede contribuir a la foto sensibilidad*** PRECAUCIONES: (Continuacion)***que resulta en irritacin de la piel y enrojecimiento en las personas expuestas a la luz solar intensa o a cabinas de bronceado. Evitar en pacientes con riesgos de hemorragia, tomando anticoagulantes o con desordenes de coagulacion basados en informes de casos de hemorragias. Descontinue su uso 2-3 semanas antes de alguna cirugia o procedimiento dental debido al incremento del riesgo de hemorragia. Use con precaucion en pacientes con antecedentes de convulsiones basados en informes de convulsiones debidas a la ingestion de la semilla de Ginkgo.*** PRECAUCIONES (Continuacion):*** Use cuidadosanemente en ninos. Evitese en parejas que estan tratando de concebir, sobre la base teorica de reduccion de fecundidad.*** Este producto es fabricado y envasado en una instalacion que tambien puede procesar leche, soya, trigo, huevos, mani, pescado y crustaceos.*** Esta declaracion no ha sido evaluada por la Administracion de Drogas y Alimentos-FDA. Este producto no tiene como finalidad diagnosticar, tratar, curar o prevenir ninguna enfermedad.***". THE ENGLISH TRANSLATION PROVIDED BY THE FIRM: "***Ceretal (Activator of Cerebral Metabolism) Increases mental agility, concentration and memory*** Ceretal is a complete formula for the brain, 100% natural. It contains more effective and studied nutrients and herbs that provide optimal support for the mind, providing mental agility, focus, concentration and clarity. It contains 8 highly effective ingredients that supports our brains neuronal capacity, providing nutrients that a healthy brain needs to operate at maximum performance.*** Improves and restores memory*** Restores agility*** Increases clarity*** Eliminates mental fatigue*** SUGGESTED USE: As a dietary supplement, take (1) capsule daily. Do not take more than 2 capsules per day.*** CAUTION: The herb, St. John's Wort may contribute to photosensitivity that results in skin irritation and redness in people exposed to intense sunlight or tanning booths. Avoid in patients with hemorrhage risks, taking anticoagulants or coagulation based on reports of bleeding disorders. Discontinue use 2-3 weeks prior to any surgery or dental prcedures due to the increased risk of bleeding. Use cautiously in patients with a history of seizures, based on reports of seizures due to ingestion on Ginkgo seed. Use carefully on children. Avoid in couples who are trying to conceive because of fertility risks.*** This product is manufactured and packaged in a facility that can also process milk, soy, wheat, eggs, peanuts, fish and crustaceans.*** These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, prevent or cure any disease***". Recall # F-0994-2012;
 
8) Diavan, Corti-Therm, Capsule, 100mg /200mg. Each bottles contains 60 capsules. THE SPANISH BOOKLET IS LABELED IN PARTS: "***DIAVAN (Formula Dietetica Avanzada)***MIRGEN PHARMACEUTICAL*** Impulsador de energia y supresor de apetito. Quemador de calorias y grasas*** DIAVAN esta formulada con una lista de ingredientes efectivos para ayudar a aumentar la energia y el metabolismo. Con la perfecta formulacion cientifica por capsula, cada una incluye una mezcla unica de Hoodia Cactus, corteza de Magnolia, Banaba, L-teanina, Te Verde, Cromo y mucho mas*** Suprime el apetito*** Regula la azucar en la sangre para reducir los antojos*** Incrementa la quema de calorias*** Diuretico natural y estimulante suave*** Aumenta el metabolismo y quema las grasas ayudando a reducir la retencion de grasas en el centro del cuerpo.*** USO SUGERIDO: Como suplemento dietetico, tomar una (1) capsula temprano en la manana con 8 oz de agua y una (1) capsula temprano en la tarde con 8 oz de agua. Este producto debe utilizarse en union con una dieta sana y un programa de ejercicios.*** PRECAUCIONES: No exceda la dosis recomendada.***No esta recomendado a mujeres embarazadas o lactantes ni a ninos menores de 18 anos de edad o personas tomando medicamentos recetados por el doctor. Descontinue inmediatamente su uso si se presentan nauseas, insomnio o nerviosismo. No use este producto si tiene una condicion medica conocida como hipertension arterial, diabetes, enfermedad cardiovascular, o cardiaca, hipertiroidismo, si esta tomando medicamentos antidepresivos. Si tiene preguntas acerca de la conveniencia*** PRECAUCIONES: (Continuacion)***de tomar este medicamento, consulte con su medico antes de utilizar este o cualquier suplemento dietetico. ADVERTENCIA: Este producto contiene 217 mg de cafena por porcion (equivalente a 2 tazas de cafe). Este producto es fabricado y envasado en una instalacion que tambin puede procesar leche, soya, trigo, huevos, mani, pescado y crustaceos. Esta declaracion no ha sido evaluada por la Administracion de Drogas y Alimentos- FDA. Este producto no tiene como finalidad diagnosticar, tratar, curar o prevenir ninguna enfermedad***". THE ENGLISH TRANSLATION PROVIDED BY THE FIRM: "***Diavan (Advanced Diet Formula)***Energy booster and appetite suppressor. Burns calories and fat.*** Diavan is formulated with a list of effective ingredients to help increase energy and metabolism. With the perfect scientific formulation per capsule, each includes a unique blend of Hoodia Cactus, bark of Magnoila, Banaga, green tea, L-theanine, chrome and much more.*** Suppresses appetite*** Regulates blood sugar*** Reduces cravings*** Increases calorie burning*** Natural diuretic and mild stimulant*** Increases metabolism and burns fat, reducing retention of belly fat*** SUGGESTED USE: As a dietary supplement, with 8 oz. of water taken one (1) capsule early in the morning, and one (1) capsule with 8 oz. of water early in the afternoon. This product should be used in conjunction with a healthy diet and an exercise program.*** CAUTION: Do not exceed the recommended dose. It is not recommended for pregnant or nursing women or children under 18 years of age or persons taking medication prescribed by the doctor. Immediately discontinue its use if there is nausea, insomnia and nervousness. Do not use this product if you have a medical condition known as high blood pressure, diabetes, cardiovascular or heart disease, hyperthyroidism, of if you are taking anti-depressant drugs. If you have questions about taking this drug, consult with your doctor before using this or any dietary supplement.*** WARNING: This product contains 217 mg. of caffeine per serving (equivalent to 2 cups of coffee). This product is manufactured and packaged in a facility that can also process milk, soy, wheat, eggs, peanuts, fish and crustaceans.*** This statement has not been evaluated by the food-FDA and drug administration. This product is not intended to diagnose, treat, cure or prevent any disease***". Recall # F-0995-2012;
 
9) Duerme y Adelgaza, Bedtime weight loss, Capsule, 400 mg. Each bottle contains 60 capsules. THE SPANISH BOOKLET IS LABELED IN PARTS: "***DUERME Y ADELGAZA (Bed time weight loss)***MIRGEN PHARMACEUTICAL***Promueve la capacidad natural del cuerpo para perder peso, mientras esta relajado o duerme.*** Es una formula cientificamente probada para bajar de peso incrementando la capacidad natural del cuerpo para procesar los residuos y aumentando el flujo sanguineo y el metabolismo incluso mientras esta en un estado de reposo. Facilita la reduccion de grasa corporal, al mismo tiempo que aumenta la masa muscular e inhibe la absorcion de grasas en la dieta. Arginina, el ingrediente principal de Duerme y Adelgaza, parece estimular el crecimiento muscular y ayuda con la presion arterial y la circulacion en general.*** Incrementa: Metabolismo*** Niveles de la hormona de crecimiento*** Digestion*** Oxidacion de la grasa*** Masa muscular*** Circulacin sanguinea*** Reduce el tejido grasoso del cuerpo*** Arginina se transforma en oxido nitrico, causando la relajacion de los vasos sanguineos yse dice que ayuda coneldolorenel lecho, obstrucciondelasarterias (ateroesclerosis), disfuncionerectil, insuficiencia cardiaca einflamacionde los vasos sanguineos que causan algunos doloresdecabeza.*** USO SUGERIDO*** Como suplemento dietetico tomar uno (1) a dos (2) comprimidos al dia. Para obtener mejores resultados, tomar con el estomago vacio por lo menos 2 horas antes o despues de comer y antes de acostarse.*** PRECAUCIONES: No exceder la dosis recomendada. Mujeres embarazadas o en lactancia, ninos menores de 18 anos, y personas con una condicion medica conocida deben consultar a un medico antes de usar este o cualquier otro suplemento dietetico. Este producto es fabricado y envasado en una instalacin que tambien puede procesar leche, soya, trigo, huevos, mani, pescado y crustaceos. Esta declaracion no ha sido evaluada por la Administracion de Drogas y Alimentos- FDA. Este producto no tiene como finalidad diagnosticar, tratar, curar o prevenir ninguna enfermedad***". THE ENGLISH TRANSLATION PROVIDED BY THE FIRM: Sleep and Eat (Bed time weight loss)***Promotes the bodys natural ability to lose weight, while it is relaxed or asleep.*** It is a scientifically proven weight loss formula that increases the bodys natural ability to process waste and increase the blood flow and metabolism even while in a resting state. It facilitates the reduction of body fat while increasing muscle mass and inhibits the absorption of fat in the diet. Arginine, the main ingredient of Sleep and Eat seems to stimulate muscle growth and helps with blood pressure and general circulation.*** It increases: Metabolism*** Growth hormone levels*** Digestion*** Fat oxidation*** Muscle mass*** Blood circulation*** It reduces oily body tissue.*** Arginine becomes nitric oxide, causing relaxation of the blood vessels and is said to help with pain while in bed, blockage of the arteries (atherosclerosis), erectile dysfunction, heart failure, and inflammation of the blood vessels that cause some headaches.*** SUGGESTED USE: As a dietary supplement, take one (1) to two (2) tablets per day. For best results, take with an empty stomach for at least 2 hours before or after eating and before bedtime.*** CAUTION: Do not exceed the recommended dose. Pregnant or nursing women, children under the age of 18 years, and people with a known medical condition should consult a physician before using this or any other dietary supplement. This product is manufactured and packaged in a facility that can also process milk, soy, wheat, eggs, peanuts, fish and crustaceans*** This statement has not been evaluated by the food-FDA and drug administration. This product is not intended to diagnose, treat, cure or prevent any disease***". Recall #F-0996-2012;
 
10) Eneria Pura, Power Band, Capsule , 1.5 mg. Each bottle contains 60 capsules. THE SPANISH BOOKLET IS LABELED IN PARTS: "***ENERGIA PURA (Power band)***8 Horas de EnergIa Formula Avanzada Te da energia durante el dia sin el azucar y las calorias de las bebidas energeticas.***El agotamientomentalyfisico eslares puestanaturaldelcuerpoal esfuerzo fisico, estres emocional, ofalta de sueno. Normalmente, buscamos una solucionrapida como una taza de cafe o bebidasenergeticas azucaradas.*** El problemaes quelosestimulantesolo proporcionan unimpulso energetico temporal maximo de una hora. Peoraun, despues dedesa-parecer el efecto, tusniveles de energia se desploman y tedejanaun mas agotado queantes.*** Energia Pura ha sido desarrollada paradaratucuerpo la energiaque Necesitas de una manera segura paramantenertusniveles de energia pormastiempo. Dehecho, paralamayoriade lagente, unadosis deEnergia Pura enla manana los mantiene activados todo el dia.*** USO SUGERIDO: Como suplemento diettico tomar uno (1) a dos (2) comprimidos al dia.*** PRECAUCIONES: No exceder la dosis recomendada. Mujeres embarazadas o en lactancia, ninos menores de 18 anos, y personas con una condicion medica conocida deben consultar a un medico antes de usar este o cualquier otro suplemento dietetico*** PRECAUCIONES (Continuacion): Este producto es fabricado y envasado en una instalacion que tambien puede procesar leche, soya, trigo, huevos, man, pescado y crustaceos. ADVERTENCIAS: Este producto contiene 100 Mg. de cafeina por porcion. (Equivalente aproximadamente a una taza de cafe).*** Esta declaracion no ha sido evaluada por la Administracion de Drogas y Alimentos-FDA. Este producto no tiene como finalidad diagnosticar, tratar, curar o prevenir ninguna enfermedad***". THE ENGLISH TRANSLATION PROVIDED BY THE FIRM: "***Pure Energy (Power Band) ***8 Hours of Advanced Energy Gives you energy throughout the day without the sugar and calories of energy drinks*** Mental and physical exhaustion is a natural response of your body to physical efforts, emotional stress, or lack of sleep. Normally, one looks for a quick fix like a cup of coffee or a sugary energy drink. The problem is that the stimulant only provides a temporary boost of energy for not more than an hour. After which, your energy level plummets and leaves you even more exhausted than before*** Pure Energy has been developed to give your body the energy that you need to maintain your energy levels longer. In fact, for most people, a dose of Pure Energy in the morning keeps them active throughout the day*** SUGGESTED USE: As a dietary supplement, take one (1) of two (2) tablets per day.*** CAUTION: Do not exceed the recommended dose. Pregnant or nursing women, children under 18 years of age, and people with a known medical condition should consult a physician before using this or any other dietary supplement*** This product is manufactured and packaged in a facility that can also process milk, soy, wheat, eggs, peanuts, fish and crustaceans*** WARNINGS: This product contains 100 mg. of caffeine per serving. (Equivalent approximately to 1 cup of coffee.)*** This statement has not been evaluated by the food - FDA and drug administration. This product is not intended to diagnose, treat, cure or prevent any disease". Recall # F-0997-2012;
 
11) Extracto de Arandano, Cranberry Extract, Capsule, 1000 mg, each bottle contains 60 capsules. THE SPANISH BOOKLET IS LABELED IN PARTS: "***EXTRACTO DE JUGO DE ARANDANO (Cranberry Juice Extract)-1000 mg*** Previene y detiene la infeccion urinaria*** Puede ayudar a reducir el dano de las celulas cerebrales*** Ayuda a prevenir la caries dental*** Inhibe el crecimiento de las celulas cancerosas*** Arandano e su Tracto Urinario*** El extracto de jugo de arandano hace la orina mas acida y esta forma de acido tiene un fuerte efecto antibacterial. El Arandano provee un ambiente inhospito a las bacterias evitando que se adhieren a las paredes de la tracto urinario ayudando a prevenir y tratar las infecciones urinarias*** El extracto de Arandano tambien actua como desodorizante de la orina y es una buena fuente de vitamina C*** Arandano e las Celulas del Cerebro*** Los cientificos han encontrado que el extracto de Arandano tambien puede ayudar en la recuperacion despues de un derrame cerebral especialmente en las etapas tempranas cuando el dano mas severo ocurre*** Arandando e Caries Dental*** Inhibe la adherencia de bacteria en los dientes que causa la caries dental.*** Arandano e Crecimiento de las Celulas Cancerosas*** Inhibe la adherencia de bacteria en los dientes que causa la caries dental.*** ADVERTENCIA: Personas con historia de calculos al rinon deben consultar al doctor antes de usarlo por un periodo de tiempo prolongado*** USO SUGERIDO*** Como suplemento dietetico tomar una (1) o dos (2) capsulas por dia o segun lo recomendado por un profesional de la salud*** PRECAUCIONES: Mantener fuera del alcance de los ninos. No utilice si el sello impreso debajo de la tapa falta o est danado*** Esta declaracion no ha sido evaluada por la Administracion de Drogas y Alimentos-FDA. Este producto no tiene como finalidad diagnosticar, tratar, curar o prevenir ninguna enfermedad***". ENGLISH TRANSLATION BY THE FIRM: "***Extract of the Juice of the Cranberry (Cranberry Juice Extract) 1,000 mg. Helps prevent and stop bladder infection. Helps prevent tooth decay. Helps prevent the growth of cancer cells. Cranberry and your Urinary Tract Cranberry juice makes the urine more acidic and this form of acid has a strong antibacterial effect. Cranberry provides an inhospitable environment for bacteria to stock to the walls of the urinary tract helping to prevent and treat bladder infections*** Cranberry extract also acts as a urine deodorant and is a good source of vitamin C*** Cranberry and your brain cells*** Scientists have found that cranberry extract can also help in the recovery after a brain stroke particularly in the early stages when the most severe damage occurs*** Cranberry and Dental Care*** It inhibits the adhesion of bacteria on the teeth that causes tooth decay*** Cranberry and the Growth of Cancerous Cells*** It inhibits the adhesion of bacteria on the teeth that causes tooth decay*** Warnings: Persons with a history of kidney stones should consult a doctor before using it for an extended period of time*** SUGGESTED USE: As a dietary supplement take one (1) or two (2) capsules per day or as recommended by a health professional*** CAUTION: Keep out of reach of children. Do not use if printed seal under cap is missing or damaged*** This statement has not been evaluated by the Food and Drug Administration- FDA. This product is not intended to diagnose, treat, cure of prevent disease”. Recall # F-0998-2012;
 
12) Flexartil 3X (CS/GS/MSM Complex), Capsule, 1200,1500 2000. Each bottle contains 200 capsules. THE SPANISH BOOKLET IS LABELED IN PARTS: "***FLEXARTIL 3X (Condroitina/Glucosamina/MSM)***MIRGEN PHARMACEUTICAL***Lubrica, Refuerza y Regenera las Articulaciones*** Promueve la formacion y reparacion del cartIlago*** Ayuda a reducir el dolor e inflamacion de huesos y musculos*** Alivia los sintomas de artritis*** Flexartil 3X combina los tres principales componentes que ayudan a la restauracion de las articulaciones y ligamentos.*** Glucosamina: Su funcion principal es estimular las sustancias necesarias para la obra de reparacion de lasarti-culaciones ya que algunas personas carecende esta capacidad o tienen un impedimento para fabricarlas debido a su edad. Tambien proporciona alivio a dolores leves. Condroitina: Junto con Glucosamina ayuda a reconstruir el cartlago de las articulaciones.*** Ya que los cartlagos no tienen ningun suministro de sangre, todo su alimento y lubricacion viene del liquido que fluye por el movimiento de las articulaciones. Sin este fluido, el cartilago se desnutre, reseca, adelgaza y se vuelve mas fragil. Condroitina atrae liquido hacia los cartilagos. Este liquido actua como un amortiguador esponjoso, transportando los nutrientes necesarios*** MSM: es el azufre orgnico el cual el cuerpo puede absorber y usar. El azufre es un elemento necesario para mantener los cartilagos saludables. El azufre es encontrado en la comida, sin embargo la mayor parte del azufre volatil es perdido al lavar o cocinar los alimentos. Debido a su semejanza quimica con el azufre, MSM ha mostrado ser eficaz en el alivio de la inflamacion, tiene propiedades que alivian el dolor y ayuda a que la Glucosamina haga su trabajo mas eficazmente.*** USO SUGERIDO: Como suplemento dietetico, tomar cinco (5) capsulas a dia.*** PRECAUCIONES: No exceder la dosis recomendada. Este producto no esta destinado a personas con alergias a los crustaceos. Mujeres embarazadas o en lactancia, ninos menores de 18 anos, y personas con una condicion medica conocida deben consultar a un medico antes de usar este o cualquier otro suplemento dietetico. Este producto es fabricado y envasado en una instalacion que tambien puede procesar leche, soya, trigo, huevos, mani, pescado y crustaceos*** Esta declaraciOn no ha sido evaluada por la AdministraciOn de Drogas y Alimentos-FDA. Este producto no tiene como finalidad diagnosticar, tratar, curar o prevenir ninguna enfermedad***". THE ENGLISH TRANSLATION PROVIDED BY THE FIRM: "***FlexArtil 3X (Condroitin / Glucosamin / MSM)*** Lubricated, reinforces and regenerated the jointsPromotes the formation and repair of cartilage.*** Helps reduce pain and inflammation of bones and muscles*** Relieves the symptoms of arthritis*** FlexArtil 3X combines the three main components that help in the restoration of the joints and ligaments.*** Glucosamine: Its main function is to stimulate the necessary substances that some people cannot manufacture naturally due to their age to repair the joints. It also provides relief from mild headaches.*** Chondroitin: Along with Glucosamine helps to rebuild the cartilage of the joint. Cartilage does not have a blood supply. All of the food and lubrication comes from the liquid that flows through the movement of the joints. Without this fluid, cartilage becomes dry. It thins and becomes more fragile Chondroitin draws fluid into the cartilage. This fluid acts as a spongy shock absorber, transporting nutrients.*** MSM: is organic sulfur which the body absorbs and uses. Sulfur is a necessary element to maintain healthy cartilage. Sulfur is found in food, but most of the volatile sulfur is lost to washing and cooking our food. Due to the chemical resemblance to sulfur, MSM has shown to be effective in reliving inflammation. It has properties that relieve pain and aid Glucosamine to work more effectively*** SUGGESTED USE: As a dietary supplement, take five (5) capsules per day.*** CAUTION: Do not exceed the recommended does. This product is not intended for persons with allergies to crustaceans. Pregnant or nursing women, children under 18 years of age, and people with a known medical condition should consult a physician before using this or any other dietary supplement. This product is manufactured and packaged in a facility that can also process milk, soy, wheat, eggs, peanuts, fish and crustaceans.*** These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, prevent or cure any disease***". Recall # F-0999-2012;
 
13) Inhibidel (Cheat and Eat), Tablet, 25 mg. Each bottle contains 90 Tablet. THE SPANISH BOOKLET IS LABELED IN PARTS: "***INHIBIDEL (Cheat and Eat)***MIRGEN PHARMACEUTICAL***Bloqueador de Grasa y Azucar*** Inhibidel, es un nuevo y sorprendente y unico suplemento dieteticoqueayuda abloquearel excesodegrasay azucaren lo queconsumes. 100% seguroy natural,cada comprimido contiene 1000mg. deChitosane Ingredientes naturalesqueactuancomo imanesdegrasayazucar atrapando lagrasa sin digerir y bloqueando la absorcion deazucarantesdequetu cuerpo los convierta en kilos de mas.*** Ayuda a perder peso sin cambiar tus habitos alimenticios y estilo de vida*** Cada tableta puede bloquear hasta 12 gramos de grasa o mas.*** No contiene estimulantes*** Seguro para usar todos los dias*** Inhibidel te satisface mientras pierdes peso. El deseode tucerebropor grasaestasatisfecho yaque siguescomiendolo quete gusta y gracias a que gran parte de lagrasanoesdigerida escomo sinuncalo hubieras comido.*** USO SUGERIDO*** Como suplemento dietetico tomar uno (1) a dos (2) comprimidos 30-45 minutos antes de las comidas. No exceder de seis (6) tabletas por dia. Este producto debe utilizarse en union con una dieta sana y un programa de ejercicios*** PRECAUCIONES: No exceder la dosis recomendada. Este producto no esta destinado a personas con alergias a los mariscos. Las mujeres embarazadas o en lactancia, ninos menores de 18 anos, y las personas con una condicion medica conocida deben consultar a*** PRECAUCIONES: (Continuacion) un medico antes de usar este o cualquier otro suplemento dietetico.*** Este producto es fabricado y envasado en una instalaci0n que tambien puede procesar leche, soya, trigo, huevos, mani, pescado y crustaceos.*** Esta declaracion no ha sido evaluada por la Administracion de Drogas y Alimentos- FDA. Este producto no tiene como finalidad diagnosticar, tratar, curar o prevenir ninguna enfermedad***". THE ENGLISH TRANSLATION PROVIDED BY THE FIRM: "***Inhibidel (Cheat and Eat)***Fat and Sugar Blocker Inhibidel is a new and surprising unique dietary supplement which helps to block excess fate and sugar in what you consume. 100% safe and natural, each capsule contains 1000 mg of Chitosan, a natural ingredient that acts as a magnet for catching undigested fat and blocking the absorption of sugar before your body turns them into extra pounds.*** Helps with weight loss without changing your eating habits and lifestyle*** Each tablet can block up to 12 fat grams or more*** It contains no stimulants*** Safe to use everyday*** Inhibidel satisfies you while you lose weight. The desire of your brain for fat is satisfied since you continue to eat what you like because much of the fat is undigested it is as if you never ate it.*** SUGGESTED USE: As a dietary supplement, take one (1) or two (2) tablets 30-45 minutes before meals. Do not exceed six (6) tablets per day. This product should be used in conjunction with a healthy diet and an exercise program***. CAUTION: Do not exceed the recommended dose. This product is not intended for persons with allergies to shellfish. Pregnant or nursing women, children under the age of 18, and persons with a known medical condition should consult a physician before using this or any other dietary supplement.*** This product is manufactured and packaged in a facility which may also process milk, soy, wheat, egg, peanuts, fish and crustacean shellfish.*** These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, prevent or cure any disease***". Recall # F-1000-2012;
 
14) Inmuneral (Juice Complex), Coated Tablet, 300 mg Acai, each bottle contains 60 coated Tablets. THE SPANISH BOOKLET IS LABELED IN PARTS: "***INMUNERAL (Juice Complex)***MIRGEN PHARMACEUTICAL*** Antioxidante para fortalecer la salud en general*** Fortificado con Resveratrol 50mg es una mezcla de extractos de moras y frutas con propiedades antioxidantes.*** Ayuda a:*** Fortalecer la salud a nivel celular*** Fortalecer las defensas naturales del cuerpo*** Estabilizar el colesterol*** Fortalecer el corazon, la prostata la vision y digestion*** Combatir los efectos de la diabetes*** Contiene:*** Fruta de Acai, Goji, Sarzamoras, Noni, Mangostino y Granada que son frutas ricas en antioxidantes que interfieren con el envejecimiento y la adquisicion de enfermedades*** USO SUGERIDO*** Como suplemento dietetico, tomar una (1) o dos (2) capsulas dos veces al dia o segun lo recomendado por un profesional de la salud.*** PRECAUCIONES:*** No exceder la dosis recomendada. Mujeres embarazadas o lactantes, ninos menores de 18 anos o personas con una condicion medica conocida debe consultar a su medico*** PRECAUCIONES: (Continuacion)*** antes de usar este o cualquier suplemento dietetico. Este producto es fabricado y envasado en una instalacion que tambien puede procesar leche, soya, trigo, huevos, mani, pescado y crustaceos.*** Esta declaracion no ha sido evaluada por la Administracion de Drogas y Alimentos-FDA. Este producto no tiene como finalidad diagnosticar, tratar, curar o prevenir ninguna enfermedad.***". THE ENGLISH TRANSLATION PROVIDED BY THE FIRM: "***Inmuneral (Juice Complex)***Antioxidant to strengthen the overall health Fortified with Resveratrol 50 mg is a blend of extracts of blackberries and fruits with antioxidant properties.*** It helps to:*** Strengthen health at the cellular level*** Strengthen the bodys natural defenses*** Stabilize cholesterol*** Strengthen the heart , prostate, vision and digestion*** Combat the effects of diabetes*** Contains:*** Acai, Goji, Sarzamoras, Noni, Mangosteen and Granada which are fruit rich in antioxidants that interfere with the acquisition of diseases and aging.*** SUGGESTED USE: As a dietary supplement, take one (1) or two (2) capsules twice daily or as recommended by a health professional.*** CAUTION: Do not exceed the recommended dose. Pregnant and nursing women, children under the age of 18 or persons with a known medical condition should consult their physician before using this or any dietary supplement.*** This product is manufactured and packaged in a facility that can also process milk, soy, wheat, eggs, peanuts, fish and crustaceans.*** This statement has not been evaluated by the food-FDA and drug administration. This product is not intended to diagnose, treat, cure or prevent any disease. Recall # F-1001-2012;
 
15) Omega 3, Softgel, 1000 mg, each bottle contains 100 softgel. THE SPANISH BOOKLET IS LABELED IN PARTS: "***OMEGA 3***MIRGEN PHARMACEUTICAL*** Aceite De Pescado Concentrado*** Omega 3 es un aceite que producen los peces de aguas muy frias que minimiza en los seres humanos el riesgo de padecer arterioesclerosis (endurecimiento de las arterias) y la formacion de colesterol. Es mas frecuentemente usado para trastornos relacionados con el corazon y el sistema sanguineo y ha ganado la reputacion de "alimento para el cerebro" debido a que algunas personas lo comen como ayuda para la depresion, trastorno de deficit de atencion e hiperactividad*** La evidencia cientifica sugiere que el aceite de pescado realmente baja los trigliceridos altos y parece tambien prevenir las enfermedades del corazon y derrames cerebrales cuando se toma en las dosis recomendadas. En general el Omega 3 es la respuesta para una mejor salud, mas alta energia y para prevenir muchas enfermedades como:*** Enfermedades cardiacas Artritis Cancer Depresion Alzheimer Diabetes*** Algunas personas usan el aceite de pescado para: Sequedad de los ojos Glaucoma Prevencion de los dolores de menstruacion, el dolor de los senos y las complicaciones asociadas con el embarazo Asma Trastornos en el desarrollo de la coordinacion Obesidad Debilidad de los huesos (osteoporosis)*** USO SUGERIDO*** Como suplemento dietetico tomar una (1) o dos (2) capsulas por dia o segun lo recomendado por un profesional de la salud.*** PRECAUCIONES: Mantener fuera del alcance de los ninos. No utilice si el sello impreso debajo de la tapa falta o esta danado*** Esta declaracion no ha sido evaluada por la Administracion de Drogas y Alimentos-FDA. Este producto no tiene como finalidad diagnosticar, tratar, curar o prevenir ninguna enfermedad. THE ENGLISH TRANSLATION IS PROVIDED BY THE FIRM: "***Omega-3 Fish Oil Concentrate*** Omega 3 is an oil produced by the fish of very cold waters. It minimizes the risk of arteriosclerosis (hardening of the arteries) and the formation of cholesterol in humans. It is most often used for disorders related to the heart and blood system, and has earned the reputation of food for the brain because some people say it aids depression, hyperactivity and attention deficit disorder.*** Scientific evidence suggests that fish oil lowers the high triglycerides and seems also to prevent diseases of the heart and stroke when taken at recommended doses. In general, the Omega 3 is the answer to better health, higher energy and to prevent many diseases, such as:*** Heart disease Arthritis Cancer Depression Alzheimer's Diabetes*** SUGGESTED USE: As a dietary supplement take one (1) or two (2) capsules per day or as recommended by a health Professional.*** CAUTION: Keep out of the reach of children. Do not use if printed seal under cap is missing or damaged.*** This statement has not been evaluated by the Food and Drug Administration- FDA. This product is not intended to diagnose, treat, cure of prevent disease". Recall # F-1002-2012;
 
16) Presion Arterial (Blood pressure 90's), Capsule, 60 mg. Each bottle contains 90 capsules. THE SPANISH BOOKLET IS LABELED IN PARTS: "***PRESION ARTERIAL (Blood Pressure Support)***MIRGEN PHARMACEUTICAL***Beneficia la salud en general y ayuda a mantener la presion arterial saludable. Se estima que la presion arterial alta mata a mas de 50.000 personas en USA cada ano. La presion arterial es algo que debe ser tomado muy en serio. Se ha demostrado que hay muchos compuestos naturales que ayudan a mantener una presin arterial normal.*** Presion Arterial de MIRGEN contiene 14 ingredientes naturales que han de-mostrado efectos positivos sobre los sintomas de la presion arterial alta. A continuacion se enumeran algunos.*** Niacina es un vasodilatador natural, que ensancha los vasos sanguineos, lo que resulta en disminucion de presion contra las paredes de los vasos.*** El acido folico ayuda a mantener la flexibilidad de los vasos sanguineos.*** Flor de Hibiscus, Espino blanco y hoja de oliva se ha demostrado tener efectos antihipertensivos. Gayuba*** Coralillo y hoja de Buchu y vitamina B6 son diureticos que ayudan a liberar el cuerpo del exceso de liquido haciendo que baje la presion arterial.*** USO SUGERIDO: Como suplemento dietetico, tomar una (1) capsula dos veces al dia.*** PRECAUCIONES: No exceder la dosis recomendada. Este producto no esta recomendado a mujeres embarazadas o lactantes ni a ninos menores de 18 anos de edad o personas con una condicion medica conocida incluyendo desordenes cardiovasculares, hipotension (presion*** PRECAUCIONES: (Continuacion)*** sanguinea baja) si esta tomando cualquier medicamento prescrito incluyendo para la presion alta y tiene preguntas acerca de la conveniencia de tomar este producto, consulte su medico antes de usarlo. Este producto es fabricado y envasado en una instalacion que tam-bien puede procesar leche, soya, trigo, huevos, mani, pesca-do y crustaceos.*** Esta declaracion no ha sido evaluada por la Administracion de Drogas y Alimentos-FDA. Este producto no tiene como finalidad diag-nosticar, tratar, curar o prevenir ninguna enfermedad***". THE ENGLISH TRANSLATION PROVIDED BY THE FIRM: "***Blood Pressure (Blood Sugar Support)***Benefits overall health and helps maintain healthy blood pressure*** It is estimated that high blood pressure kills more than 50,000 people in the U.S. each year. Blood pressure is something that should be taken seriously. It has shown that there are many natural compounds that help maintain a normal blood pressure.*** Mirgen's Presion Arterial contains 14 natural ingredients that have demonstrated positive effects on symptoms of high blood pressure. Some are listed below. Niacin is a natural vasodilator, which widens the blood vessels, which results in a decrease of pressure against the walls of the vessels. Folic acid helps to maintain the flexibility of blood vessels. Hibiscus flower, Hawthorn and Olive Leaf have shown to have antihypertensive effects. Bearberry, Coralillo and Buchu Leaf and Vitamin B6 are diuretics that help rid the body of excess fluid making blood pressure lower.*** SUGGESTED USE: As a dietary supplement, take (1) capsule two times per day.*** CAUTION: Do not exceed recommended dose. This product is not recommended for pregnant or nursing women or children under 18 years of age or people with a known medical condition including cardiovascular disorders, hypotension (low blood pressure). If you are taking any prescription medication including for high blood pressure and have any questions about the advisability of taking this product, consult your doctor before using it*** This product is manufactured and packaged in a facility that also can process milk, soy, wheat, eggs, peanut, fish and crustaceans*** This statement has not been evaluated by the Food and Drug Administration. This product is not intended diagnose, treat, cure or prevent any disease." Recall # F-1003-2012;
 
17) Purgasin (Parasite Complex 60's), Tablet, 5 mg Zinc. THE SPANISH BOOKLET IS LABELED IN PARTS: "***PURGASIN (Parasite Formula)***MIRGEN PHARMACEUTICAL***Formula contra parasitos*** Incluye 18 hierbas claves y otros*** nutrientes importantes en una formula*** de las mas potentes disponibles.*** Beneficios:*** Reduce la fatiga*** Mejora el estado de animo*** Apoya el proceso natural de desintoxicacion del higado.*** Usado para limpiar el cuerpo de los parasitos intestinales*** Ayuda a limpiar el colon de los residuos y productos quimicos*** Debilita o rompe las membranas protectoras del parasito*** Ayuda a oxigenar la sangre ayudando en la eliminacion de los parasitos*** Mata a ciertos parasitos y ayuda a "limpiar" los parasitos y sus huevos*** Ayuda al sistema inmunologico a combatir la infeccion de bacterias y parasitos*** Ayuda en la digestion y a reducir los espasmos intestinales*** USO SUGERIDO: Como suplemento diettico, tomar dos (2) capsulas con las comidas tres (3) veces al dia durante diez (10) dias. Repetir en dos o tres semanas si es necesario.*** PRECAUCIONES: No exceder la dosis recomendada, ni usar por un periodo de mas de diez dias. Este producto no esta destinado a mujeres embarazadas o lactantes ni a ninos menores de 18 anos de edad. Las personas con una condicion medica*** PRECAUCIONES: (Continuacion) conocida deben consultar a un medico antes de usar este o cualquier otro suplemento dietetico. Este producto es fabricado y envasado en una instalacion que tambien puede procesar leche, soya, trigo, huevos, mani, pescado y crustaceos. Esta declaracion no ha sido evaluada por la Administracion de Drogas y Alimentos- FDA. Este producto no tiene como finalidad diagnosticar, tratar, curar o prevenir ninguna enfermedad.***. THE ENGLISH TRANSLATION IS PROVIDED BY THE FIRM: "***Purgasn (Parasite Formula)***Formula against parasites*** It includes 18 key herbs and other important nutrients in a formula of the most powerful available. Benefits: Reduces fatigue Improves mood Supports the natural process of detoxification of the liver Used to clean the body of intestinal parasites Helps clean the colon of waste and chemical products Weakens or breaks the protective membranes of the parasite Helps to oxygenate the blood assisting in the elimination of parasites Kills certain parasites and helps clean parasites and their eggs Helps the immune system to fight infection from bacteria and parasites Helps in digestion and reduce intestinal spasms*** SUGGESTED USE: As a dietary supplement, take two (2) capsules with meals three (3) times a day for ten (10) days. Repeat in two or three weeks if necessary.*** CAUTION: Do not exceed the recommended dose or use for a period of more than ten days. This product is not intended for pregnant or nursing women or children under 18 years of age. People with a known medical condition should consult a physician before using this or any other dietary supplement.*** This product is manufactured and packaged in a facility that can also process milk, soy, wheat, eggs, peanuts, fish and crustaceans.*** This statement has not been evaluated by the Food and Drug Administration- FDA. This product is not intended to diagnose, treat, cure of prevent disease." Recall # F-1004-2012;
 
18) Sabila (Cape Aloe, Cleanse 90's), Capsule, 250 mg, each bottle contains 90 capsules. THE SPANISH BOOKLET IS LABELED IN PARTS: "***SABILA (Aloe del Cabo)***MIRGEN PHARMACEUTICAL***intestinales completas, regulares y saludables.*** ESTIMULA y FORTALECE el movimiento muscular del colon.***La formula de Sbila combina varios laxantes naturales como Aloe del cabo que es 22 veces mas potente que todas las otras especies de sabila y cascara sagrada con los efectos calmantes de la pimienta africana. La Formula de Sabila puede utilizarse para el alivio del estrenimiento ocasional (irregularidad).*** USO SUGERIDO*** Uso oral en adultos y ninos mayores de 15 anos: Tomar una (1) capsula al dia a la hora de acostarse o cuando la necesite con 8 onzas de agua, jugo o bebida de preferencia. No tomar mas de una capsula en 24 horas. Consultar a un medico antes de administrar a ninos menores de 15 anos de edad.*** PRECAUCIONES:*** No exceder la dosis recomendada. Lea y siga las instrucciones cuidadosamente. Este producto contiene Aloe del Cabo (Aloe Ferox), Cascara sagrada y hoja de Zen. No esta recomendado a mujeres embarazadas o lactantes ni a ninos menores de 18 anos de edad. No use este producto si tiene dolor abdominal, diarrea o deposicinn blanda. No lo use por mas de una semana. No exceda la dosis diaria recomendada. Sangrado rectal y/o falta de evacuacion intestinal despues del uso de una formula laxante puede ser una indicacinn de una condicion mas seria.*** PRECAUCIONES: (Continuacion)*** Si esto ocurre o si tiene una condicion medica conocida y esta tomando medicinas debe consultar a un medico antes de usar este o cualquier otro suplemento dietetico. Este producto es fabricado y envasado en una instalacion que tambien puede procesar leche, soya, trigo, huevos, mani, pescado y crustaceos.*** Esta declaracion no ha sido evaluada por la Administracion de Drogas y Alimentos-FDA. Este producto no tiene como finalidad diagnosticar, tratar, curar o prevenir ninguna enfermedad.***". THE ENGLISH TRANSLATION PROVIDED BY THE FIRM: "***Sabila (Cape Aloe)*** It promotes naturally complete, regular and healthy bowel movements. It stimulates and strengthens the muscle movement of the colon. The Aloe Vera formula combines several natural laxatives with Cape Aloe which is 22 times more powerful than all other species of Aloe Vera and cascara sagrada with the soothing effects of the African pepper. This Aloe Vera formula can used for the relief of occasional constipation (irregularity).*** SUGGESTED USE: Oral use in adults and children older than 15 years, take one (1) capsule a day at bedtime or when you need it with 8 ounces of water, juice or beverage of choice. Do not take more than one capsule within 24 hours. Consult a doctor before administering to children under 15 years of age.*** PRECAUTIONS: Do not exceed the recommended dose. Read and follow the instructions carefully. This product contains Cape Aloe (Aloe Ferox), shiny sacred and blades Zen. It is not recommended for pregnant or nursing women or to children under 18 years of age. Do not use this product if you have abdominal pain, diarrhea or soft stool. Do not use for more than one week. Do not exceed the recommended daily dose. Rectal bleeding and/or lack of bowel evacuation after using one formula laxative may be indication of a more serious condition. If this happens, or if you have a known medical condition and are taking medication, consult your physician before using this or any other dietary supplement. This product is manufactured and packaged in a facility that can also process milk, soy, wheat, eggs, peanuts, fish and crustaceans.*** This statement has not been evaluated by the Food and Drug Administration-FDA. This product is not intended to diagnose, treat, cure of prevent disease." Recall # F-1005-2012;
 
19) Terma Trim (Therma Trim EF), Coated Tablet, 25 mg. Each bottle contains 90 coated tablets. THE SPANISH BOOKLET IS LABELED IN PARTS: "***TERMA TRIM***Formula SUper Quema Grasa Baja de Peso y Medidas de una forma RApida y Segura*** 100 % natural, para bajar de peso mediante su exclusiva formula de efecto termogenico . Te ayuda a disminuir el porcentaje de grasa corporal acumulado en el organismo resultando en la perdida de peso, y medidas sin reducir el porcentaje muscular.*** "Quemacalorasrpidamente*** "Ayudaapreservarlamasamuscular*** "Mejorala absorcindenutrientes*** "Ayudaareducir lagrasacorporal*** " Ayuda a alcanzar mayoresniveles deenergia USO SUGERIDO*** Como suplemento dietetico tomar una (1) tableta con 8 onzas de agua, 30-45 minutos antes del desayuno y del almuerzo. No exceder de dos (2) tabletas por dia. Este producto debe utilizarse en unin con una dieta sana y un programa de ejercicios.*** PRECAUCIONES: No exceder la dosis recomendada. Este producto no esta destinado a mujeres embarazadas o en lactancia, ninos menores de 18 anos o personas que toman medicamento recetados por un doctor. Descontinue inmediatamente su uso si se presentan nauseas, insomnio o nerviosismo. Si tiene una condicion medica conocida como hipertension arterial, diabetes, enfermedad cardiovascular, o cardiaca, hipertiroidismo, si esta tomando medica-mentos antidepresivos o si tiene alguna pregunta acerca de la conveniencia.*** PRECAUCIONES: (Continuacion)*** de tomar este medicamento, consulte con su medico antes de utilizar este o cualquier suplemento dietetico. ADVERTENCIA: Este producto contiene 100 mg de cafeina por porcion (equivalente a 1 taza de cafe).*** Este producto es fabricado y envasado en una instalacion que tambien puede procesar leche, soya, trigo, huevos, mani, pescado y crustaceos. Esta declaracion no ha sido evaluada por la Administracion de Drogas y Alimentos- FDA. Este producto no tiene como finalidad diagnosticar, tratar, curar o prevenir ninguna enfermedad***". THE ENGLISH TRANSLATION PROVIDED BY THE FIRM: "***Terma Trim - Super Fat Burning Formula*** Weight loss and measurement in a fast and safe way*** 100% natural weight loss through its exclusive thermogenic formula effect. It helps you to decrease the percentage of body fate accumulated in the body resulting in the loss of weight and measurements without reducing the percentage of muscle. Burns calories quickly*** Helps preserve muscle mass*** Improves the absorption of nutrients*** Helps to achieve higher levels of energy*** SUGGESTED USE: As a dietary supplement, take one (1) tablet with 8 oz. of water, 30-45 minutes before breakfast and lunch. Not more than two (2) tablets per day. This product should be used in conjunction with a healthy diet and exercise program. *** CAUTION: Do not exceed the recommended dose. This product is not intended for pregnant or nursing women, children under the age of 18 years or people taking prescription medication. Immediately discontinue us if you experience nausea, insomnia or nervousness. If you have a known medical condition such as high blood pressure, diabetes, cardiovascular or heart disease, hyperthyroidism, if you are taking antidepressant medications, or if you have any questions about the advisability of taking this medicine, check with your physician before using this or any dietary supplement.*** WARNING: This product contains 100 mg. of caffeine per serving (equivalent to 1 cup of coffee). This product is manufactured and packaged in a facility that can also process milk, soy, wheat, eggs, peanuts, fish and crustaceans.*** These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, prevent or cure any disease***". Recall # F-1006-2012
CODE
1) Lot 72835, expiration date August 2013; Lot 61613, expiration date July 2013; Lot 81732, expiration date September 2013, Lot 42215, expiration date May 2013;
 
2) Lot 61168 expiration August 2013; Lot 11131 expiration January 2013; Lot 89119 October 2013;
 
3) Lot 11831 expiration date March 2013; Lot 3029 expiration date November 2013;
 
4) Lot 52302 expiration date June 2013; Lot 11823 expiration date February 2013, Lot 31713 expiration date May 2013;
 
5) Lot 12913 expiration date May 2013; Lot 32218 expiration date May 2013; Lot 81123 expiration date September 2013;
 
6) Lot 52303 expiration date August 2013; Lot 90309 expiration date October 2013;
 
7) Lot 52306, expiration date June 2013; Lot 71107, expiration date November 2013;
 
8) Lot 32219, expiration May 2013;
 
9) Lot 33001, expiration April 2013; Lot 91019, expiration October 2013; Lot 81520, expiration October 2013;
 
10) Lot 12916, expiration October 2013; Lot 12327, expiration December 2012;
 
11) Lot 340816 Expiration March 2013;
 
12) Lot 81157, Expiration August 2013; Lot 91159, Expiration October 2013;
 
13) Lot 2715, Expiration November 2012;
 
14) Lot 11716, Expiration January 2013; Lot 81111, Expiration September 2013;
 
15) Lot 341577, Expiration November 2013; Lot 340946, Expiration January 2013;
 
16) Lot 20913, expiration January 2013; Lot 61614, expiration July 2013;
 
17) Lot 60803, Expiration July 2013; Lot 20921, Expiration January 2013; Lot 33003, Expiration April 2013;
 
18) Lot 12325, expiration January 2013; Lot 40528, expiration April 2013;
 
19) Lot 72832, expiration August 2013; Lot 81116, expiration September 2013; Lot 21647, expiration March 2013
RECALLING FIRM/MANUFACTURER
Recalling Firm: Mirgen Pharmaceutical, Boise, ID, by visit on January 12, 2012 and by letter dated February 17, 2012.
Manufacturers: Magno Humphries Inc., Tigard, OR;
Vitalabs, Inc., Jonesboro, GA. FDA initiated recall is ongoing.
REASON
The booklet around the neck of the dietary supplement bottle makes unapproved drug claims in Spanish. The original manufacturer's label was covered by the distributor's sticker label.
VOLUME OF PRODUCT IN COMMERCE
2223 bottles of 19 products
DISTRIBUTION
ID, OR
 
The FDA begins a pilot program seeking to expedite notifications of human drug product recalls to the public. The agency will modify the drug product section of the Enforcement Report, published every Wednesday, to include actions that have been determined to be recalls, but that remain in the process of being classified as a Class I, II, or III action. Such recalls will be listed under the heading, “Recalls Pending Classification: DRUGS.” They will be reposted with their classification once that determination has been made. Send comments or suggestions to CDERRecallPilot@fda.hhs.gov.
 
RECALLS PENDING CLASSIFICATION: DRUGS
______________________________________
PRODUCT
Pramipexole Dihydrochloride Tablets, 0.125 mg, Rx only, 90 Tablets: NDC 00781-53248-92.
CODE
Lot # BJ3186, Exp. 12/12; BJ3142, Exp. 12/12.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Sandoz Incorporated
Manufacturer: Sandoz Private Limited
REASON FOR RECALL
Impurities/Degradation Products: Product is being recalled due to an out-of-specification result for known degradant impurity at the 12-month stability timepoint.
_____________________________________
PRODUCT
Alka-Seltzer Plus, Severe Sinus Congestion, Allergy & Cough Formula, 40 Liquid Gels (NDC # 0280-1195-40)
CODE
Lot Number: NAA04N7, Exp. 09/13; NAA04N8, Exp. 01/14.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bayer Healthcare, LLC, Morristown, NJ
Manufacturer: Bayer Healthcare LLC Consumer Care Division, Myerstown, PA
REASON FOR RECALL:
Labeling: Label Mixup: The maximum number of capsules to be taken in 24 hours on the labeling strip does not match the statement on the carton.
 
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II
___________________________________
PRODUCT
1) 0.9% Sodium Chloride Injection, USP, 250mL bags, Rx only, NDC 0409-7983-02. Recall D-1290-2012;
 
2) 1g Lidocaine, (4mg/mL), 250 ml, 0.4% Lidocaine HCl and 5% Dextrose Inj. USP, 250mL bags, Rx only, NDC 0409-7931-32. Recall # D-1291-2012
CODE
1) Lot #94-833-KL, Exp. 10/12;
2) Lot #92-643-KL; Exp. 02/12
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hospira, Inc., Lake Forest, IL, by letter on January 20, 2012.
Manufacturer: Hospira, Inc., Rocky Mount, NC. Firm initiated recall is ongoing.
REASON
Superpotent Drug: Due to confirmed out-of-specification results for in-process chemical assay during lot specific protocol testing. (** Note: Even though lidocaine and dextrose IV bag are considered a multiple ingredient drug, the sodium chloride bag is a single ingredient drug).
VOLUME OF PRODUCT IN COMMERCE
86,712 bags
DISTRIBUTION
Nationwide and Canada
________________________________
PRODUCT
1) Equate Maximum Strength Antacid Cherry 12 Fl Oz. bottle (355 mL) UPC 078742092706. Recall # D-1295-2012;
 
2) Select Brand Infants' Gas Relief Drops 1 FL OZ. (30 mL) UPC 015127004770. Recall # D-1296-2012;
 
3) Pedia Care Infants Gas Relief Drops (Simethicone), 1 FL OZ (30 mL) UPC 814832011253. Recall # D-1297-2012;
 
4) Smart Sense Antacid Anti-Gas Original Flavor 12 FL OZ (355 mL) UPC 072000156148 Recall # D-1298-2012;
 
5) Smart Sense Infants' Gas Relief Drops Non-Staining Formula 1 FL OZ. (30 mL) UPC 072000761434. Recall # D-1299-2012;
 
6) Sunmark Gas Relief Drops Infants' 1 Fl Oz. (30 mL) UPC 010939132338. Recall # D-1300-2012;
 
7) DG Health Infants Gas Relief Liquid Drops 1 Fl Oz (30 mL) UPC 053041620096. Recall # D-1301-2012;
 
8) Discount Drug Mart Food Fair Antacid Anti-Gas Extra Strength Original Flavor 12 Fl Oz. (355 mL) UPC 093351101403. Recall # D-1302-2013;
 
9) Discount Drug Mart Food Fair Infants' Gas Relief Liquid Drops (Simethicone 20mg), 1 FL OZ (30mL) UPC 093351123894. Recall # D-1303-2012;
 
10) CVS Pharmacy Antacid Liquid Maximum Strength 355 mL (12 FL OZ) UPC 050428077276. Recall # D-1304-2012;
 
11) QC Quality Choice Infants' Gas Relief Drops 1 FL OZ (30 mL) UPC 635515981409. Recall # D-1305-2012;
 
12) Good Neighbor Pharmacy Infants' Gas Relief Drops 1 FL Oz. (30 mL) UPC 087701485855. Recall # D-1306-2012;
 
13) Pedia Care Infants Gas Relief Drops (Simethicone) Dye Free Non-Staining 1 FL OZ (30 mL) UPC 814832011246. Recall # D-1307-2012
CODE
1) Lot Number Exp Date 508- 2459 02/2013 508-2460 02/2013 508-2461 02/2013 508-2462 02/2013 508-2473 02/2013 508-2474 02/2013 508-2475 02/2013 508-2476 02/2013 508-2818 04/2013 508-2819 04/2013 508-2820 04/2013 508-2835 04/2013 508-2836 04/2013 508-2852 04/2013 508-2853 04/2013 508-2909 04/2013 508-2910 05/2013;
 
2) Lot Number Expiry Date 520-1597 06/2012 520-1900 09/2012 520-2056 11/2012 520-2492 02/2013 520-2516 02/2013 520-2958 05/2013;
 
3) Lot Number Expiry Date 521-1849 08/2012 521-2048 10/2012 521-2512 02/2013 521-2517 04/2013;
 
4) Lot Number Exp Date 516-1999 10/2012 516-2367 01/2013 516-2577 02/2013 516-2846 04/2013 516-3067 06/2013 516-3147 06/2013;
 
5) Lot Number Expiry Date 520-1641 06/2012 520-1900 09/2012 520-2492 02/2013 520-2516 02/2013;
 
6) Lot Number Expiry Date 521-1642 07/2012 521-1870 09/2012 521-2057 11/2012 521-2857 04/2013 521-3108 06/2013;
 
7) Lot Number - Exp Date 520-1597 06/2012 520-1641 06/2012 520-1807 08/2012 520-1900 09/2012 520-2056 11/2012 520-2172 11/2012 520-2492 02/2013 520-2516 02/2013 520-2711 03/2013 520-2773 04/2013 520-2958 05/2013 520-3104 06/2013 520-3155 06/2013;
 
8) Lot Number, Expiry Date 516-1999 10/2012;
 
9) Lot Number Expiry Date 520-1641 06/2012 520-2492 02/2013;
 
10) Lot Number Exp. Date 508-1596 06/2012 508-1810 08/2012 508-1853 09/2012 508-1951 09/2012 508-1992 10/2012 508-2085 11/2012 508-2108 11/2012 508-2236 12/2012 508-2272 12/2012 508-2273 12/2012 508-2319 01/2013 508-2433 02/2013 508-2434 02/2013 508-2477 02/2013 508-2647 03/2013 508-2648 03/2013 508-2649 03/2013 508-2650 03/20 13 508-3065 05/2013 508-3066 05/2013;
 
11) Lot Number Expiry Date 520-1597 06/2012 520-1900 09/2012 520-2056 11/2012 520-2958 05/2013;
 
12) Lot Number Expiry Date 521-1642 07/2012 521-1870 09/2012 521-2057 11/2012 521-2857 04/2013 521-3108 06/2013;
 
13) Lot Number Expiry Date 520-1829 08/2012 520-2047 10/2012 520-2488 02/2013 520-2513 02/2013 520-2515 02/2013 520-2660 03/2013
RECALLING FIRM/MANUFACTURER
Guardian Drug Co., Dayton, NJ, on website and by letters dated March 7, 2012. Firm initiated recall is ongoing.
REASON
Microbial Contamination of Non-Sterile Product: Simethicone containing products may be contaminated with B. cepacia due to a raw material that was used to manufacture the product.
VOLUME OF PRODUCT IN COMMERCE
1,181,484 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
DOXOrubicin HCl INJECTION, USP, a) 10 mg (2 mg/mL), STERILE, ISOTONIC SOLUTION, 5 mL Single Dose Vial, NDC 63323-883-30, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 60173 DOXOrubicin HCl INJECTION, USP, b) 20 mg (2 mg/mL), STERILE, ISOTONIC SOLUTION, 10 mL Single Dose Vial, NDC 633323-883-10, Rx only, APP Pharmaceuticals, LLC Schaumberg, IL 60173 DOXOrubicin HCl INJECTION, USP, c) 50 mg (2 mg/mL), STERILE, ISOTONIC SOLUTION, 25 mL Single Dose Vial, NDC 63323-0883-30, Rx only, DOXOrubicin HCl INJECTION, USP, d) 200 mg (2 mg/mL), STERILE, ISOTONIC SOLUTION, 100 mL Mulitple Dose Vial, NDC 63323-0101-61, Rx only. Recall # D-1309-2012
CODE
a) Lot # 6102054 Item # 208-5538 expiration date 6/2013 b) Lot # 6101933-expiration date 06/2013, Lot # 6102057-expiration date 07/2013 c) Lot # 6102499-expiration dates 09/2013, Lot #s 6102706 & 6102787-expiration date 10/2013 d) Lot # 6102639, expiration dates 10/2013
RECALLING FIRM/MANUFACTURER
Recalling Firm: H D Smith Wholesale Drug Co., Pompano Beach, FL, by telephone on January 20, 2012 and by letter on January 23, 2012.
Manufacturer: App Pharmaceuticals LLC, Schaumburg, IL. Firm initiated recall is ongoing.
REASON
Temperature Abuse: Product was stored outside of the manufacturer refrigeration guidelines; Store in a refrigerator 2 to 8 degrees celcius.
VOLUME OF PRODUCT IN COMMERCE
72 vials
DISTRIBUTION
FL
___________________________________
PRODUCT
CYANOCOBALAMIN INJECTION, USP, 1000 mcg/mL, 1 mL vial, packaged in 25 x 1 mL vials per pack, Rx only, NDC 0517-0031-25. Recall # D-1310-2012
CODE
Lot #: 1662, 1679, 1683, Exp 11/13
RECALLING FIRM/MANUFACTURER
Luitpold Pharmaceuticals, Inc., Shirley, NY, by letters and/or facsimile on April 2, 2012. Firm initiated recall is ongoing.
REASON
Lack of Assurance of Sterility: Container leakage from cracks formed in the heel (bottom) and sides of some of the vials may lead to a lack of assurance of sterility and the potential for the development and presence of glass particulates.
VOLUME OF PRODUCT IN COMMERCE
535,825 vials
DISTRIBUTION
Nationwide and Puerto Rico
___________________________________
PRODUCT
Good Neighbor Pharmacy, Night Time Liquid Caps, acetaminophen, dextromethorphan HBr, doxylamine succinate, Multi Symptom Cold/Flu Relief, 12 softgels per blister cards, NDC 24385-0035-53. Recall # D-1311-2012
CODE
Units: X05350, X07080, X14328, X17788, X23422
RECALLING FIRM/MANUFACTURER
Recalling Firm: Pl Developments, Inc., Westbury, NY, by e-mail on February 29, 2012.
Manufacturer: Banner Pharmacaps Inc., High Point, NC. Firm initiated recall is ongoing.
REASON
Labeling: Label Mix-up: Good Neighbor Pharmacy brand Night Time Liquid Caps are being recalled because the labeling states Antihistamine Free when the product contains an antihistamine.
VOLUME OF PRODUCT IN COMMERCE
22,368 blister cards
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Midodrine Hydrochloride Tablets, 5 mg, 100-count tablets per bottle, Rx only, NDC 0185-0043-01. Recall # D-1312-2012
CODE
Lot number: BT0643, Exp 06/13
RECALLING FIRM/MANUFACTURER
Recalling Firm: Sandoz Inc., Princeton, NJ, by letter on/about February 21, 1012 and reissued letter on April 9, 2012.
Manufacturer: Sandoz Inc., Wilson, NC. Firm initiated recall is ongoing.
REASON
Tablet Thickness: This product is being recalled due to out of specification (above and below) results for tablet weight and above specification for tablet thickness.
VOLUME OF PRODUCT IN COMMERCE
7088 bottles
DISTRIBUTION
Nationwide
 
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III
___________________________________
PRODUCT
Treanda (bendamustine HCl) for Injection, 25 mg/vial, lyophilized powder in a Single Use Vial, Rx Only, NDC 63459-390-08, UPC 3 63459 390 08 6. Recall # D-1308-2012
CODE
Lot #: TB30411, Exp 03/31/2013
RECALLING FIRM/MANUFACTURER
Recalling Firm: Cephalon, Inc., Malvern, PA, by letter on March 15, 2012.
Manufacturer: Baxter Oncology GmbH, Halle/Westfalen, Germany. Firm initiated recall is ongoing.
REASON
Impurities/Degradation Products: Product is being recalled due to an Out of Specification result for an impurity in Lot Number TB30411 of Treanda(R) 25 mg (8 mL vial).
VOLUME OF PRODUCT IN COMMERCE
20,175 vials
DISTRIBUTION
Nationwide and Puerto Rico
 
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0770-12
CODE
Units: 21LG43705; 21LK28258
RECALLING FIRM/MANUFACTURER
American National Red Cross, Portland, OR, by telephone on November 27, 2006 and follow up letter dated December 4, 2006. Firm initiated recall is complete.
REASON
Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
WA and OR
________________________________
PRODUCT
Recovered Plasma. Recall # B-0822-12
CODE
Units: 004FT08256, 004KK74676, 004KM41251, 004KQ16253
RECALLING FIRM/MANUFACTURER
Recalling Firm: Arc Blood Services, New England Region, Dedham, MA, by e-mail on January 6, 2012.  
Manufacturer: ARC/Manchester, NH, Manchester, NH. Firm initiated recall is complete. 
REASON
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 unts
DISTRIBUTION
CA
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-0846-12;
2) Plasma Frozen Within 24 hours (FP24). Recall # B-0847-12
CODE
1) and 2) Unit: 06FW27089
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Pomona, CA, by telephone on October 4, 2008 and by letter dated October 9, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0886-12
CODE
Unit: 6417728
RECALLING FIRM/MANUFACTURER
Recalling Firm: New York Blood Center, Inc., New York, NY, by facsimile and telephone on November 20, 2006. 
Manufacturer: New York Blood Center, Inc., Westbury, NY. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY
___________________________________
PRODUCT
Source Plasma. Recall # B-0887-12
CODE
Units: 0421405351, 0421383543, 0421382861, 0421380916, 0421380136, 0421378310, 0421377719, 0421357020, 0421352671, 0421352411, 0421350694, 0421350548, 0421348970, 0421348360, 0421346548, 0421345580, 0421343910, 0421343131, 0421341485, 0421341057 0421339344, 0421338482, 0421336968, 0421336190, 0421334651, 0421333986, 0421332547, 0421331718, 0421330073, 0421329222, 0421327680, 0421326982, 0421325587, 0421324846, 0421323426, 0421322059, 0421321284, 0421319919, 0421319162
RECALLING FIRM/MANUFACTURER
Recalling Firm: CSL Plasma, Inc., Boca Raton, FL, by electronic database notification on September 18, 2009.   
Manufacturer: CSL Plasma, Inc., Lansing, MI. Firm initiated recall is complete.
REASON
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
39 units
DISTRIBUTION
IL, Switzerland and Germany
________________________________
PRODUCT
Source Plasma. Recall # B-0888-12
CODE
Units: 00042000, 00050944, 00054553, 00058889, 00062862, 00067911, 00084352, 00087353, 00091510, 00095839, 00105101, 00153447, 00156806, 00164436, 00167741, 00172714, 00175364, 00186971, 00189392, 00343336, 00347167, 00355575, 00358576, 0420966365, 0420967067, 0420967879, 0420968145, 0420968586, 0420970068, 0420970396, 0420971334, 0420971940, 0420972445, 0420972929, 0421037851, 0421039057, 0421039504, 0421042177, 0421043960, 0421044252, 0421045807, 0421046348, 0421047583, 0421047808, 0421049623, 0421050163, 0421050676, 0421051012, 0421051680, 0421243990, 0421244819, 0421247223, 0421248398, 0421249496, 0421251412, 0421251766, 0421253428, 0421254003, 0421255284, 0421257432, 0421258628, 0421259871, 0421260810, 0421262160, 0421263219, 0421264651, 0421266467, 0421267519, 0421268504, 0421269461, 0421270320, 0421271442, 0421273486, 0421274273, 0421275368, 0421277505, 0421278544, 0421279701, 0421280411, 0421280839, 0421281209, 0421283617, 0421306553, 0421312097, 0421312820, 0421314054, 0421315096, 0421322568, 0421323244, 0421328301, 0421329484, 0421331099, 0421331816, 0421338243, 0421339234, 0421341669, 0421343664, 0421345000, 0421346094, 0421347405, 0421348626, 0421349754, 0421350722, 0421351471, 0421352753, 0421353722, 0421355369, 0421356265, 0421357756, 0421359088, 0421360891, 0421361755, 0421363310, 0421364345, 0421366073, 0421366830, 0421371465, 0421372287, 0421374073, 0421376054, 0421377394, 0421378525, 0421380939, 0421382292, 0421384361, 0421385853, 0421387102, 0421387102, 0421387769, 0421387831, 0421387831, 0421388373, 0421390500, 0421390500, 0421390717, 0421392574, 0421393572, 0421394704, 0421394704, 0421395921, 0421396685, 0421397103, 0421397103, 0421399502, 0421399502, 0421400696, 0421400729, 0421400729, 0421402083, 0421402563, 0421402563, 0421403444, 0421405013, 0421406076, 0421406239, 0421406239, 0421407371, 0421407371, 0421407658, 0421409094, 0421409094, 0421409107, 0421410165, 0421411559, 0421412904, 0421414425, 0421416070, 0421417714, 0421418719, 0421418721, 0421418721, 0421420843, 0421420843, 0421421043, 0421421167, 0421421167, 0421421256, 0421423358, 0421423922, 0421424714, 0421424714, 0421426115, 0421426672, 0421426672, 0421426884, 0421428806, 0421428963, 0421428963, 0421429482, 0421429482, 0421431543, 0421431766, 0421431766, 0421432219, 0421432219, 0421432345, 0421434142, 0421434725, 0421436249, 0421436249, 0421436551, 0421437148, 0421437148, 0421439760, 0421440348, 0421443227, 0421443869, 0421445499, 0421446030, 0421446122, 0421446122, 0421446594, 0421446594, 0421447496, 0421448394, 0421449845, 0421450649, 0421452638, 0421455514, 0421455869, 0421455869, 0421456059, 0421456789, 0421456789, 0421457800, 0421458272, 0421458272, 0421458396, 0421460800, 0421463601, 0421464172, 0421464172, 0421468055, 0421470022, 0421470693, 0421470823, 0421472059, 0421472585, 0421472585, 0421472781, 0421474118, 0421474591, 0421476104, 0421477176, 0421479735, 0421480362, 8790001463, 8790002299, 8790003511, 8790004413, 8790006225, 8790011535, 8790012510, 34 CJBLYF, 34 CJBLZW, 34 CJBMKV, 34 CJQGYY, 34 CJQHMX, 34 CJQHRJ, 34 CJQJCX, 34 CJQJKK, 34 CJQJXZ, 34 CJQLVX, 34 CJQLZH, 34 CJQMBL, 34 CJQMHT, 34 CJQMQP, 34 CJQMXY, 34 CJQNBT, 34 CJQTHV, 34 CJQTQL, 34 CJQTTR, 34 CJQVHN, 34 CJQVQX, 34 CJQWLG, 34 CJRFQY, 34 CJRGHD, 62 GLGBKD, 62 GLGBVT, 62 GLGCLB, 62 GLGCWS, 62 GLGDKR, 62 GLGDVJ, 62 GLGFHV, 62 GLGGHR, 62 GLGGTW, 62 GLGHHV, 62 GLGHXJ, 62 GLGHXS, 62 GLGJLC, 62 GLGJTK, 62 GLGKJJ, 62 GLGKTQ, 62 GLGLFX, 62 GLGMDL
RECALLING FIRM/MANUFACTURER
Recalling Firm: CSL Plasma, Inc., Boca Raton, FL, by facsimile and electronic mail on February 10, 2010, February 12, 2010 and April 13, 2010. Manufacturer: CSL Plasma, Inc., Lansing, MI. Firm initiated recall is complete.
REASON
Blood products, collected from donors with a history of high risk behaviors, were distributed.
VOLUME OF PRODUCT IN COMMERCE
295 units
DISTRIBUTION
IL, NC, MA, Switzerland and Germany
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0891-12
CODE
Units: 084C43055
RECALLING FIRM/MANUFACTURER
The recalling firm notified the by letter dated August 9, 2006. Firm initiated recall is complete.
REASON 
Blood product, which was not quarantined after receiving information concerning a post donation illness, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0902-12
CODE
Unit: LL81145
RECALLING FIRM/MANUFACTURER
Rhode Island Blood Center, Providence, RI, by letter on December 28, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
RI
___________________________________
PRODUCT
1) Red Blood Cells. Recall # B-0914-12;
2) Red Blood Cells Leukocytes Reduced. Recall # B-0915-12;
3) Platelets. Recall # B-0916-12;
4) Fresh Frozen Plasma. Recall # B-0917-12
CODE
1) Units: 004J98555; 004E02363; 004G89009;
2) Units: 004V01027; 004V83719;
3) Units: 004J98555; 004G89009;
4) Unit: 004J98555
RECALLING FIRM/MANUFACTURER
ARC Blood Services, New England Region, Dedham, MA, by facsimile on February 20, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from donors who were previously deferred, were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units
DISTRIBUTION
MA, ME, NY
________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0949-12
CODE
Unit: 2932984
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, San Francisco, CA, by telephone and follow-up letter notification dated May 11, 2006. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
1) Fresh Frozen Plasma. Recall # B-0950-12;
2) Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-0951-12
CODE
1) and 2) Units: 8751000; 8223565
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, San Francisco, CA, by telephone and follow-up letter on April 12, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at risk for HIV Group O, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
CA
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-0958-12;
2) Platelets Pooled Leukocytes Reduced. Recall # B-0959-12
CODE
1) Units: Units: 5797945; 5770461;
2) Unit: 5802123
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc., Orlando, FL, by letter dated October 24, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
FL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0963-12
CODE
Unit: 9479690
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc., Orlando, FL, by letter dated August 18, 2008. Firm initiated recall is complete
REASON
Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0968-12
CODE
Unit: 6256668
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc., Orlando, FL, by letter dated October 17, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-0973-12
CODE
Units: W067111081713; W067111063972; W067111084324; W067111063959; W067111060202; W067111086011; W067111070711; W067111074279; W067111063961; W067111059196; W067111087415; W067111070706; W067111073244
RECALLING FIRM/MANUFACTURER
The Blood Center, New Orleans, LA, by telephone on January 30, 2012. Firm initiated recall is complete.
REASON
Blood products, labeled with an incorrect expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE
13 units
DISTRIBUTION
LA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0974-12
CODE
Unit: 22KR00408
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn Jersey Region, Philadelphia, PA, by facsimile and letter on December 21, 2011. Firm initiated recall is complete.
REASON
Blood product, labeled RBC antigen negative tested RBC antigen positive, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NJ
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0975-12
CODE
Unit: W115911046079
RECALLING FIRM/MANUFACTURER
Central California Blood Center, Fresno, CA, by facsimile on January 20, 2012. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MD
________________________________
PRODUCT
Red Blood Cells. Recall # B-0985-12
CODE
Unit: P67921
RECALLING FIRM/MANUFACTURER
Delta Blood Bank, Stockton, CA, by e-mail and letter dated January 19, 2007. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA, Austria
___________________________________
PRODUCT
Red Blood Cells. Recall # B-0987-12
CODE
Unit: 2035738
RECALLING FIRM/MANUFACTURER
Southeastern Community Blood Center, Tallahassee, FL, by facsimile dated February 27, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor taking the medication Avodart, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL, Austria
 
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III
___________________________________
PRODUCT
Source Leukocytes. Recall # B-0821-12
CODE
Unit: W035212058945P
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by e-mail on February 16, 2012. Firm initiated recall is complete. 
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NJ
___________________________________
PRODUCT
1) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-0889-12;
2) Platelets Pheresis Leukocytes Reduced. Recall # B-0890-12
CODE
1) Unit: 084C39121 (part2);
2) Unit: 084C39121 (part1)
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Oakland, CA, by letter dated November 15, 2007 and November 16, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with an invalid body temperature, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-0953-12;
2) Recovered Plasma. Recall # B-0954-12
CODE
1) and 2) Unit: 021LG38621
RECALLING FIRM/MANUFACTURER
American National Red Cross, Portland, OR, by telephone on August 21, 2006, electronically on August 22, 2006 and follow up letter dated August 23, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who reported a post donation illness, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OR
___________________________________
PRODUCT
Source Plasma. Recall # B-0972-12
CODE
Units: 6010904893; 6010904651; 6010903288; 6010902351; 6010901787; 6010900539; 6010900023; 6010899213; 6010898418; 6010896394; 6010895315; 6010894277
RECALLING FIRM/MANUFACTURER
Biotest Pharmaceuticals Corp., San Antonio, TX, by facsimile on January 9, 2012. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
12 units
DISTRIBUTION
NC
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0977-12
CODE
Unit: 021LG97820
RECALLING FIRM/MANUFACTURER
American National Red Cross, Portland, OR, by telephone and letter on December 23, 2011. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
STN BL 125306, Blood Grouping Reagent Anti-c (Monoclonal) - ALBAclone Anti-c (H48) Human/Murine Monoclonal IgM for tube technique. Recall # B-0986-12
CODE
Lot: V089866
RECALLING FIRM/MANUFACTURER
Recalling Firm: Quotient Biodiagnostics, Inc., Newtown, PA, by letter dated August 26, 2010.
Manufacturer: Alba Bioscience Limited, Edinburgh, UK. Firm initiated recall is ongoing.
REASON
ALBAclone Anti-c, with a typographical error in the package insert, was distributed.
VOLUME OF PRODUCT IN COMMERCE
475 units
DISTRIBUTION
PR, Nationwide and Canada
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0988-12
CODE
Unit: 2035738
RECALLING FIRM/MANUFACTURER
Southeastern Community Blood Center, Tallahassee, FL, by facsimile dated February 27, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor taking the medication Avodart, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL, Austria
 
RECALLS AND FIELD CORRECTIONS: DEVICES – CLASS II
___________________________________
PRODUCT
Philips Healthcare MD Eleva system. Multi-functional fluoroscopy, radiography and angiography systems that can perform more specialized interventional applications. Recall # Z-1212-2012
CODE
MultiDiagnost Eleva ll – 708036, 708032, MultiDiagnost Eleva FD – 708037, 708034
RECALLING FIRM/MANUFACTURER
Philips Healthcare, Inc., Andover, MA, by letter on November 19, 2011. Firm initiated recall is ongoing.
REASON
The air karma rate is not displayed correctly on the user interface.
VOLUME OF PRODUCT IN COMMERCE
92 (24 Eleva 11s and 68 Eleva FDs)
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Touch Panel/Control Unit Carrier of the Swingarm M820/M844 C19, article no. 10448194MO; a component of the Leica M820 C19 Surgical Microscope, a) article 10448196, and the Leica M844 C19 Surgical Microscope, b) article 10448197; ceiling mounted surgical microscopes; The intended use of the microscope is for improving the visibility of objects through magnification and illumination. It can be applied for observation and documentation and for human and veterinary medical treatment. Recall # Z-1269-2012
CODE
Serial numbers: 17091004, 20911002, 26110801, 31207001, 31207002, 61006001, 61006002, 91208002, 101208001, 101210002, 140508002, 151209002, 160806002, 260811001, 261108001 and 261108002; b) Serial numbers: 11010001, 50510002, 81007003, 110507002, 130707001, 130707003, 160910008, 180607001, 230909001, 270407006 and 300307001
RECALLING FIRM/MANUFACTURER
Recalling Firm: Leica Microsystems, Inc., Buffalo Grove, IL, by letter dated February 27, 2012.
Manufacturer: Leica Microsystems (Schweiz) Ag. Heerbrugg, Switzerland. Firm initiated recall is ongoing.
REASON
The screws, which lock the bottom plate to the spindle, pull through allowing the carrier arm with touch panel/control unit of the surgical microscope to disconnect, which potentially could result in them falling.
VOLUME OF PRODUCT IN COMMERCE
33 units (27 – Nationwide; 6 - Internationally)
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
RayStation Version 2.0.0.15, Radiation Therapy Treatment Planning System. Model RayStation 2.0. Designed for treatment planning and analysis of radiation therapy. Recall # Z-1317-2012
CODE
Software version 2.0.0.15
RECALLING FIRM/MANUFACTURER
RAYSEARCH Laboratories AB, Stockholm, Sweden, by letters on December 6, 2011. Firm initiated recall is ongoing.
REASON
An issue was found with the dose calculation, that could result in a potential overestimation of the dose. This could lead to the potential under-dosage of a patient.
VOLUME OF PRODUCT IN COMMERCE
21 devices (16 nationwide and 5 internationally)
DISTRIBUTION
Nationwide and the Netherlands
___________________________________
PRODUCT
Medtronic, Model 8870, Application Software Card is part of the SynchroMed II Drug Infusion System. The System includes the SynchroMed II implantable drug infusion pump 8637-20, 8637-40, N'Vision clinical programmer 8840 and the Software application card 8870. The SynchroMed II Infusion system contains and administers prescribed drugs to a specific site inside patient body. The SynchroMed II Pump is supplied in 20 ml and 40 ml reservoir sizes. In the United States, the SynchroMed II Pump is specifically approved for (indicated): The chronic epidural/intrathecal infusion of Infumorph (preservative-free morphine sulfate sterile solution) in the treatment of chronic intractable pain. The chronic intrathecal infusion of Lioresal Intrathecal (baclofen injection) in the management of severe spasticity. The chronic intrathecal infusion of Prialt (preservative-free ziconotide sterile solution) for the management of severe chronic pain. The chronic intravascular infusion of floxuridine (FUDR) for the treatment of primary or metastatic cancer. The chronic intravascular infusion of methotrexate for the treatment of primary or metastatic cancer. Outside of the United States, the SynchroMed II Pump is indicated for the chronic infusion of drugs or fluids tested as compatible and listed in the product labeling for the specific geographies. Recall # Z-1338-2012
CODE
All Model 8870 software application cards containing SynchroMed II software.
RECALLING FIRM/MANUFACTURER
Medtronic Neuromodulation, Minneapolis, MN, by letter on March 12, 2012. Firm initiated recall is ongoing.
REASON
Medtronic has confirmed that an algorithm used in the Model 8870 application card software has resulted in nine (9) occurrences of an incorrectly displayed Schedule to replace the pump by date. It is estimated that there are more than 140,000 SynchroMed II pump implants worldwide. A patient with a pump reaching EOS prior to replacement may experience the return of underlying symptoms and/or withdrawal symptoms. Intrathecal baclofen patients could experience baclofen withdrawal syndrome, which can be life threatening. No adverse events have been reported for eight (8) of the confirmed cases, and one Intrathecal Baclofen Therapy (ITB) patient experienced decreased therapeutic effect with increased spasticity due to the pump reaching EOS prior to replacement.
VOLUME OF PRODUCT IN COMMERCE
6,338 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Straumann Standard Plus Implant 04.8mm Wide Neck SLA 10mm Article Number: 043.652S. Dental implants are intended for surgical placement in maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients. Dental implants are for single-stage or two-stage surgery. Dental implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, four or more implants must be used. Recall # Z-1351-2012
CODE
Lot No. CW642
RECALLING FIRM/MANUFACTURER
Recalling Firm: Recalling Firm: Straumann USA, LLC, Andover, MA, by letter dated March 12, 2012.
Manufacturer: Institut Straumann AG, Basel, Switzerland. Firm initiated recall is ongoing.
REASON
Mislabeled: Vial lid label on some of the dental implant vials from this lot incorrectly state 04.8 SP 10 RN instead of 04.8 SP 10 WN.
VOLUME OF PRODUCT IN COMMERCE
346 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Brilliance 64 and Ingenuity CT Computed Tomography X-Ray Systems. Brilliance 64 Model # 728231, Ingenuity CT Model # 728326. The Brilliance 64 and Ingenuity CT are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories. Recall # Z-1361-2012
CODE
System Code #728231, 4003, 4021, 9033, 9037, 9041, 9045, 9048, 9062, 9064, 9070, 9075, 9080, 9108, 9120, 9142, 9151, 9196, 9197, 9201, 9202, 9205, 9206, 9208, 9214-9218, 9462, 9508, 9531, 9534, 9535, 9544, 9554, 9561, 9584, 9603, 9606, 9608, 9613, 9627, 9630, 9657, 9668, 9671, 9672, 9695, 9706, 9708, 9719, 9728, 9734, 9735, 9741, 9745, 9756, 9789, 9819, 9832, 9838, 9839, 9840, 9859, 9874, 9875, 9891, 9898, 9904, 9918, 9926, 9952, 9964, 9965, 9968, 9975, 9997, 9999, 10000, 10008, 10015, 10041, 10052, 10054, 10092, 10095, 10100, 10103, 10114, 10125, 10145, 10151, 10152, 10154, 10170-10172, 10192, 10196, 10198, 10221, 10222, 10251, 10256, 10273, 10286, 10294, 10307, 10312, 10336, 10337, 10350, 10352, 10362, 10363, 10372, 10376, 10380, 10386, 10393, 10412, 10425, 10426, 10428, 10438, 10445, 10446, 10452, 10459, 10461, 10468, 10470, 10471, 10473, 10482, 10486, 10489, 10491, 10493, 10497, 10503, 10505, 10511-105531, 10533-10555, 10557-10566, 10568-10575, 10577-10604, 10606, 10608-10620, 10622-10624, 10628-10640, 29037, 29049, 29057, 64040, 90036, 90054, 90058, 90063, 90080, 90100, 90102, 90106, 90117, 90135, 90169, 90182, 91003, 95015, 95055, 95065, 95074, 95077, 95101, 95108, 95130, 95133, 95138, 95140, 95157, 95168, 95174, 95178, 95184, 95185, 95191, 95207, 95243, 95295, 95315, 95324, 95327, 95350, 95357, 95358, 95362, 95389, 95403, 95414, 95425, 95429, 95443, 95455, 95504, 95516, 95529, 95534, 95568, 95570, 95572, 95573, 95575, 95602, 95605, 95609, 95613, 95624, 95630, 95638, 95652, 95659, 95664, 95665, 95677, 95684, 95687, 95697, 95700-95728 & 300074. System Code #: 728326, Serial #: 9511, 300003-300005, 300010-300022, 300024, 300025, 300027-300066 & 300068-300073
RECALLING FIRM/MANUFACTURER
Philips Medical Systems (Cleveland) Inc., Cleveland, OH, by letter dated March 14, 2012. Firm initiated recall is ongoing.
REASON
Philips Healthcare is performing an upgrade to the field for issues related to Philips Brilliance 64 and Ingenuity CT scanner having Software Version 3.5.1. When the user plans a scan with tilt applied, the scan increment changes from the user defined values (noncontiguous) to a contiguous scan.
VOLUME OF PRODUCT IN COMMERCE
440 units
DISTRIBUTION
Nationwide and Internationally
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PRODUCT
1) Servo-i ventilator system Product Usage: Intended for treatment and monitoring of patients in the range of neonates, infants and adults with respiratory failure or respiratory insufficiency. 510k k041223 B052264 Article 64 87 800. Recall # Z-1362-2012;
 
2) Servo-s ventilator system Product Usage: Intended for treatment and monitoring of patients in the range of neonates, infants and adults with respiratory failure or respiratory insufficiency. 510k k041223 B052264 Article 66 40 440. Recall # Z-1363-2012
CODE
·         1) Serial numbers 56001-58411;
·         2) Serial numbers 19841-21664
·         RECALLING FIRM/MANUFACTURER
Recalling Firm: Maquet Inc., Wayne, NJ, by letter dated December 22, 2011.
Manufacturer: Maquet Critical Care AB, Solna, Sweden. Firm initiated recall is ongoing
REASON
The Servo-i and Servo-s ventilator systems equipped with specific revision os of the AC/DC convertor can result in electric shock during servicing.
VOLUME OF PRODUCT IN COMMERCE
Servo-i- 647 US; 2462 Foreign; 27 Spare Parts Foreign; Servo-s - 50 units US
DISTRIBUTION
Nationwide
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PRODUCT
Monaco Radiation Treatment Planning System, Planning of radiation therapy. Recall # Z-1365-2012
CODE
Version 3.10.00
RECALLING FIRM/MANUFACTURER
Computerized Medical Systems Inc., Maryland Heights, MO, by letters between March 5-9, 2012. Firm initiated recall is ongoing.
REASON
An unnecessary dose refresh can occur in certain situations which causes inconsistencies in the Beam Doses and the Total Dose.
VOLUME OF PRODUCT IN COMMERCE
44 units
DISTRIBUTION
Nationwide and Internationally
 
RECALLS AND FIELD CORRECTIONS: DEVICES – CLASS III
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PRODUCT
1) SoundBite Hearing System; Microphone Tube Size 0. For use in patients with moderately severe, severe or profound sensorineural hearing loss in one ear and normal hearing in the other or patients with conductive hearing loss where the pure tone average bond-conduction hearing threshold is better than or equal to 25 dB HL. Model number a) P02011 - Right, and b) P020012 – Left. Recall # Z-1179-2012;
 
2) SoundBite Hearing System; Microphone Tube Size 1. For use in patients with moderately severe, severe or profound sensorineural hearing loss in one ear and normal hearing in the other or patients with conductive hearing loss where the pure tone average bond-conduction hearing threshold is better than or equal to 25 dB HL. Model number a) P02013 - Right, and b) P020014 - Left. Recall # Z-1180-2012;
 
3) SoundBite Hearing System; Microphone Tube Size 2. For use in patients with moderately severe, severe or profound sensorineural hearing loss in one ear and normal hearing in the other or patients with conductive hearing loss where the pure tone average bond-conduction hearing threshold is better than or equal to 25 dB HL. Model number a) P02015 - Right, and b) P020016 - Left. Recall # Z-1181-2012;
 
4) SoundBite Hearing System; Microphone Tube Size 3. For use in patients with moderately severe, severe or profound sensorineural hearing loss in one ear and normal hearing in the other or patients with conductive hearing loss where the pure tone average bond-conduction hearing threshold is better than or equal to 25 dB HL. Model number a) P02017 - Right, and b) P020018 - Left. Recall # Z-1182-2012;
 
5) SoundBite Hearing System; Microphone Tube Size 4. For use in patients with moderately severe, severe or profound sensorineural hearing loss in one ear and normal hearing in the other or patients with conductive hearing loss where the pure tone average bond-conduction hearing threshold is better than or equal to 25 dB HL. Model number a) P02019 – Right, and b) P020020 Left. Recall # Z-1183-2012
CODE
1) a) Lot M1110 and M1112; b) lot M1109, M1111 and M1113;
2) a) lot M1098, M1106; b) , lot M109, M1102 and M1107;
3) a) lot M1099; b) lot M1096, M1103;
4) a) lot M1100; b) lot M1104, M1097;
5) a) Lot M1102; b) lot M1105
RECALLING FIRM/MANUFACTURER
Sonitus Medical Inc., San Mateo, CA, by letters on February 9, 2012.
REASON
Sonitas received reports of stress cracking on the SoundBite Microphone Tube.
VOLUME OF PRODUCT IN COMMERCE
676 units
DISTRIBUTION
NC, NY, WI, TX, FL and DC
 
END OF ENFORCEMENT REPORT FOR APRIL 11, 2012
 
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