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U.S. Department of Health and Human Services

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Enforcement Report for June 21, 2006

The FDA Enforcement Report is published weekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.

June 21, 2006
06-25

RECALLS AND FIELD CORRECTIONS: FOODS AND COSMETICS -- CLASS I

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PRODUCT
Hong Kong Supermarket brand Dried Vegetable, net wt. 340 g (12 oz) --- Product of China --- Ingredients: Dried Vegetable --- Serving Size 3 oz. (85 g) --- The product is packed in a sealed plastic package with labeling in Chinese and English, UPC barcode # 0 14268 10004 4, Recall # F-201-6
CODE
UPC barcode only
RECALLING FIRM/MANUFACTURER
Recalling Firm: Mon Chong Loong Trading Corp, Maspeth, NY, by press release and letters on December 12, 2005.
Manufacturer: Lip On Trading Co., Hong Kong, China. New York State initiated recall is complete.
REASON
The product contained undeclared sulfites (3848 ppm) based on sampling and analysis by the New York State Department of Agriculture & Markets.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
NY, NJ and PA

______________________________
PRODUCT
MAIZTECA MEXICAN BREAD, 1.5 lbs. --- Ingredients: Flour, vegetable shortening (Partially Hydrogenated Soybean and/or Palm Oil), Sugar, Eggs, Cinnamon, Water, Yeast, FD & C Red #40, Red #3, Yellow #5, Blue #1, Salt. The product is packed in an uncoded flexible plastic package. Recall # F-202-6
CODE
Uncoded
RECALLING FIRM/MANUFACTURER
215 Washington St. Foods, Inc., Newburgh, NY, by letters on/about March 8, 2006. New York State Department of Agriculture & Markets issued a Consumer Alert on March 8, 2006. New York State initiated recall is complete.
REASON
The product contained undeclared milk allergen based on sampling, analysis, and inspectional findings by New York State Department of Agriculture & Markets.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
NY

______________________________
PRODUCT
Keystone Onion Flavored Rings, 4-1/8 oz. (117 g) bags, packed 12 bags to a case, Recall # F-203-6
CODE
JUN25A
RECALLING FIRM/MANUFACTURER
Keystone Food Products, Inc., Easton, PA, by telephone on April 5, 2006 and April 13, 2006, and by press release. Firm initiated recall is ongoing.
REASON
Some packages consist, in part, of nacho tortilla chips, which contain milk. There is no milk listed on the onion rings label.
VOLUME OF PRODUCT IN COMMERCE
79 cases of 12 bags
DISTRIBUTION
MA, and CT

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PRODUCT
Dried Apricots, Net Wt. 1 lb., product of Turkey. Contains no preservatives. The product is packaged in plastic containers, Recall # F-210-6
CODE
Dated 3-7 through 3-14
RECALLING FIRM/MANUFACTURER
Merex, Inc., Yonkers, NY, by press release and letter, dated March 23, 2005. Firm initiated recall is complete.
REASON
The product contained undeclared sulfites (1210 ppm) based on sampling & analysis by the New York State Department of Agriculture & Markets.
VOLUME OF PRODUCT IN COMMERCE
72 cases
DISTRIBUTION
NY

______________________________
PRODUCT
Sandwich: front label states SMOKED TURKEY ON SOURDOUGH, and the back label states TRIPLE DECKER SMOKED TURKEY. UPC code 43701 01553, Recall # F-211-6
CODE
051906
RECALLING FIRM/MANUFACTURER
Jumbo Food, Inc., Mukilteo, WA, by telephone on May 15, 2006 and by press release on May 23, 2006. Firm initiated recall is complete.
REASON
Sandwiches were contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
762 sandwiches
DISTRIBUTION
WA, OR, and ID
 

RECALLS AND FIELD CORRECTIONS: FOODS AND COSMETICS -- CLASS II

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PRODUCT
Acidified Canned Celery; #10 metal can; Label is white and green with red lettering reading in part: REDICEL *** Diced Salad Celery *** Crisp…Ready To Use *** Excellent for: * Soups and Stews * Salads -- Chicken Ham Tuna Potato Gelatin, net wt. 6 lb 6 oz, Recall # F-205-6
CODE
Lot number 1 CENS8Z6097 and 1 CENS8Y6097 ("Z" indicates the morning period / "Y" indicates the afternoon period)
RECALLING FIRM/MANUFACTURER
Recalling Firm: A Duda & Sons, Inc, Oviedo, FL, by telephone and letter on May 10, 2006 and by letter on May 15, 2006.
Manufacturer: Duda Processing & Distribution Center, Thomasville, GA. Firm initiated recall is ongoing.
REASON
Some cans of product were inadequately acidified to control the growth of pathogens of public health concern.
VOLUME OF PRODUCT IN COMMERCE
3,102 6/#10 cans
DISTRIBUTION
AL, MN, and TN

______________________________
PRODUCT
a) Tuna Salad on Multi-Grain Bread sandwiches, net wt. 5 oz. under the following labels:
a) Lil' Cindy's Sandwiches, b) Great American Deli, Recall # F-207-6;
b) Chicken Salad on Multi-Grain Bread sandwiches, net wt. 5 oz. under the following
labels:
a) Lil' Cindy's, b) Granny Green's Old Fashioned, c) Great American Deli,
Recall # F-208-6
CODE
a) Julian dates: 122, 124, and 130;
b) Julian dates: 118, 122, 124, and 129
RECALLING FIRM/MANUFACTURER
Made-Rite Sandwich Company, Inc., Ooltewah, TN, by telephone on May 12, 2006 and by memo and press release on May 23, 2006. Firm initiated recall is ongoing.
REASON
Sandwiches were manufactured using tuna salad and chicken salad which may contain a canned celery ingredient which was inadequately acidified to prevent the growth of pathogens.
VOLUME OF PRODUCT IN COMMERCE
23,339 sandwiches: Chicken 18,953, Tuna 4,386
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Big Eats Turkey On Herb Wheat Bread with Onion Chive Yogurt Spread, Pickled Banana Peppers and Romanine Lettuce. Product of Canada. Net Wt. 7.9 ox. (223 g), Recall # F-209-6
CODE
Best Before 06MA 20 (May 20, 2006)
RECALLING FIRM/MANUFACTURER
Recalling Firm: 7-11 Corporate, Dallas, TX, by telephone on May 19, 2006.
Manufacturer: 7-Eleven Canada/Richmond Food Centre, Richmond, Canada. Firm initiated recall is complete.
REASON
Sandwiches were contaminated with plastic pieces.
VOLUME OF PRODUCT IN COMMERCE
257 sandwiches
DISTRIBUTION
WA and OR
 

RECALLS AND FIELD CORRECTIONS: FOODS AND COSMETICS -- CLASS III

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PRODUCT
Buderim brand Crystallized Small Diced Ginger weighing 11.5 kg in Paper Cartons, Item No. 07045, Recall # F-204-6
CODE
15.Oct.06 (15.10.06); 01.Jul.07 (10.07.07); 15.Jul.07 (15.07.07); 20.Jul.07 (20.07.07); 21.Jul.07 (21.07.07); 23.Jul.07 (23.07.07); 25.Jul.07 (25.07.07)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Pan Pacific Foods, San Francisco, CA, by letters on May 11, 2006.
Manufacturer: The Buderim Ginger Growers' Co-Operative Assn. Ltd., Yandina, Australia. Firm initiated recall is ongoing.
REASON
The product contains undeclared sulfites.
VOLUME OF PRODUCT IN COMMERCE
573 cases/12 packages
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Spring water as follows: a) DANNON Natural Spring Water and Spring! by Dannon, in 330 ml (11.2 fl. oz.) and 500 ml (1.05 pt) bottles. The product is packaged in 15 pack, 12 pack, 6 pack or single bottles. UPC Codes: 500 ml bottles sold singly have UPCs of 0 79298 00532 5, 0 79298 0051 1, 0 79298 0050 1; 12-pack 330 ml has UPC 0 79298 13312 7 on bottle and 0 79298 033120 on multipak; 6-pack 500 ml has UPC 0 79298 00051 1 on bottle and 0 79298 00050 4 on multipak; 15-pack 500 ml has UPC 0 79298 0051 -1 on bottle and 0 79298 20001 0 on multipak; 12-pack 1000 ml has UPC 0 79298 001006 on bottle and 0 79298 010008 on multipak Note: Labeling changed in first quarter from Dannon Natural Spring Water to Spring! by Dannon. Both labels are currently on the market. b) Pure American® Spring Water * 16.9 fl. oz. (500 ml) * Bottled by CCDA Waters in Grand Prairie, TX 75050. packed in 15 pack cases UPC Code 049022 26802 9 c) HILL COUNTRY FARE® Natural Spring Water, * Sourced in Texas * Bottled by CCDA Waters in Grand Prairie, TX 75050, 16.9 fl. oz. (500 ml) and 11.2 fl. oz. (330 ml) in 12-, 6-, 24-, and 28-pack as follows: UPC Code - 0 41220 17707 3 (12-pack 330 ml), 0 41220 63089 9 (6-pack 500 ml), 0 41220 17708 0 (12-pack 500 ml), 0 41220 63091 2 (24-pack 500ml), 0 41220 78160 7 (28-pack 500 ml), Recall # F-206-6
CODE
All production dates between Nov 1, 2005 and May 16, 2006. This includes: - date codes with "GP" in the second line and dates in the first line between 05N0V1 thru 05DEC31 and 06JAN01 thru 06MAY16 - date codes with 'GP' in the first line and dates in the second line between 030106 and 051606
RECALLING FIRM/MANUFACTURER
Recalling Firm: CCDA Waters, LLC, Atlanta, GA, by telephone, fax, email and letters on May 22, 2006.
Manufacturer: CCDA Waters, LLC, Grand Prairie, TX. Firm initiated recall is ongoing.
REASON
Spring water is contaminated with algae.
VOLUME OF PRODUCT IN COMMERCE
200,000 cases
DISTRIBUTION
Nationwide

 RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II

______________________________
PRODUCT
a) Thyro-Tab, 0.025 mg, packaged in bulk 150, 000-tablet drums for repacking,
Rx Only, Recall # D-257-6;
b) Levothroid Tablets (levothyroxine sodium tablets, USP), 25 mcg, packaged in 100 and
1,000 tablet bottles, Rx only --- NDC 0456-1320-01 (100's) and NDC 0456-1320-00
(1000's), Recall # D-258-6
CODE
a) HA20205, Exp. August, 2006;
b) Lot 080524, Exp. August, 2006 (100's) and
Lot 090509, Exp. August, 2006 (1,000's)
RECALLING FIRM/MANUFACTURER
Lloyd Inc. of Iowa, Shenandoah, IA, by telephone and e-mail on April 17, 2006 and by letters dated April 19, 2006 and April 26, 2006. Firm initiated recall is ongoing.
REASON
Subpotent (6-month stability testing interval).
VOLUME OF PRODUCT IN COMMERCE
a) 1,921,835 tablets;
b) 10,110/100-tablet bottles and 870/1,000-tablet bottles
DISTRIBUTION
Nationwide

______________________________
PRODUCT
a) Citrucel Fiber Laxative Powder (methylcellulose) Fiber Therapy for Regularity,
Orange Flavor, in 16, 30, 50 and 65 oz canisters, in 0.67 oz packets and in
20 count containers, Recall # D-261-6;
b) Citrucel Fiber Laxative Sugar Free Powder (methylcellulose), Orange Flavor,
in 8.6, 16.9, 32, 42 oz canisters, 0.36 oz packets both individually and in
20 count containers, Recall # D-262-6
CODE
All lots: Item Number, Lot Number Lot Exp Date Citrucel Orange - 1 dose packet: 041810 02H074 09/30/06; 041810 02H075 09/30/06; 041810 03F223 06/30/07; Citrucel Reg. Powder 16 oz: 041817 02F467 06/30/06; 041817 02F468 06/30/06; 041817 02G327 07/31/06; 041817 02G328 07/31/06; 041817 02G329 07/31/06; 041817 02G330 07/31/06; 041817 02G331 07/30/06; 041817 02H294 08/30/06; 041817 02H295 08/30/06; 041817 02H296 08/30/06; 041817 02H297 08/30/06; 041817 02J063 09/30/06; 041817 02J064 09/30/06; 041817 02J065 09/30/06; 041817 02J066 09/30/06; 041817 02J185 09/30/06; 041817 02J186 10/30/06; 041817 02J187 09/30/06; 041817 02J188 09/30/06; 041817 02J324 09/30/06; 041817 02M209 11/30/06; 041817 02M210 11/30/06; 041817 02M211 11/30/06; 041817 02M212 11/30/06; 041817 02M213 11/30/06; 041817 02M214 11/30/06; 041817 02M215 11/28/06; 041817 02M216 11/28/06; 041817 02M218 11/28/06; 041817 03A504 01/31/07; 041817 03A505 01/31/07; 041817 03A506 01/31/07; 041817 03A507 01/31/07; 041817B 03E140 05/31/07; 041817B 03E143 05/31/07; 041817B 03E190 05/31/07; 041817B 03E191 05/31/07; 041817B 03E192 05/31/07; 041817B 03E318 06/30/07; 041817B 03E319 06/30/07; 041817B 03F192 06/30/07; 041817B 03F193 06/30/07; 041817B 03F194 06/30/07; 041817B 03F195 06/30/07; 041817B 03G154 07/31/07; 041817B 03G155 07/31/07; 041817B 03G156 07/31/07; 041817B 03G157 07/31/07; 041817B 03G158 07/31/07; 041817B 03G238 07/31/07; 041817B 03G239 07/31/07; 041817B 03H154 09/30/07; 041817B 03H155 09/30/07; 041817B 03H156 09/30/07; 041817B 03H157 09/30/07; 041817B 03H158 09/30/07; 041817B 03H159 09/30/07; 041817B 03H160 09/30/07; 041817B 03K141 09/30/07; 041817B 03K151 10/31/07; 041817B 03K152 11/30/07; 041817B 03K153 11/30/07; 041817B 03M129 11/30/07; 041817B 03M130 11/30/07; 041817B 04B086 02/28/08; 041817B 04D180 04/30/08; 041817B 04D181 04/30/08; 041817B 04E388 05/31/08; 041817B 04E389 05/31/08; 041817B 04E390 05/31/08; 041817B 04E391 05/31/08; 041817B 04E392 05/31/08; 041817B 04E393 05/31/08; 041817B 04E394 05/31/08; 041817B 04E395 05/31/08; 041817B 04H244 09/30/08; 041817B 04H245 09/30/08; 041817B 04K131 10/31/08; 041817B 04K132 10/31/08; 041817B 04K133 10/31/08; 041817B 04K134 10/31/08; 041817B 04K135 10/31/08; 041817B 04K136 10/31/08; 041817B 04N102 12/31/08; 041817B 04N103 12/31/08; 041817B 04N104 12/31/08; 041817B 04N105 12/31/08; 041817B 04N265 12/31/08; 041817B 05B165 03/31/09; 041817B 05C071 04/30/09; 041817B 05C072 04/30/09; 041817B 05D077 04/30/09; 041817B 05D078 04/30/09; 041817B 05D079 04/30/09; 041817B 05E050 06/30/09; 041817B 05E051 06/30/09; 041817B 05E052 06/30/09; 041817B 05F060 07/31/09; 041817B 05F061 07/31/09; 041817B 05G042 07/31/09; 041817B 05G043 06/30/09; 041817B 05H016 08/31/09; 041817B 05H017 08/31/09; 041817B 05J031 09/30/09; 041817B 05J032 09/30/09; 041817B 05J114 10/31/09; 041817B 05J115 10/31/09; 041817B 05J116 10/31/09; 041817B 05M160 11/30/09; 041817B 05M161 11/30/09; 041817B 05N057 01/31/10; 041817B 05N058 01/31/10; 041817B 3B28CA 11/30/06; 041817B 3C05C 11/30/06; 041817B 3C05CA 11/30/06; 041817B 3C05CB 11/30/06; 041817B 3C05CC 11/30/06; 041817B 3C05CD 11/30/06; Citrucel Orange Conv. Pack: 041825 03E414 06/30/07; 041825 03J294 09/30/07; 041825 03N168 12/31/07; 041825 03N169 12/31/07; 041825 03N170 12/31/07; 041825 04E327 05/31/08; 041825 04E328 05/31/08; 041825 04N076 12/31/08; 041825 05C469 04/30/09; 041825 4J05N 06/30/06; 041825 4J07N 06/30/06; 041825 4J11N 03/30/06; 041825 4J18N 03/30/06; Citrucel Reg Powder 30 oz: 041830 02E337 04/30/06; 041830 02E338 04/30/06; 041830 02E339 04/30/06; 041830 02E340 04/30/06; 041830 02E341 05/31/06; 041830 02E342 05/31/06; 041830 02E343 05/31/06; 041830 02E344 05/30/06; 041830 02E345 05/31/06; 041830 02G316 07/30/06; 041830 02G317 07/30/06; 041830 02G318 07/30/06; 041830 02G319 07/30/06; 041830 02G320 07/30/06; 041830 02G321 07/30/06; 041830 02G322 07/30/06; 041830 02G323 07/20/06; 041830 02G324 07/30/06; 041830 02G325 07/30/06; 041830 02G326 07/30/06; 041830 02H298 08/31/06; 041830 02H299 08/30/06; 041830 02H300 08/30/06; 041830 02H301 08/30/06; 041830 02H302 08/30/06; 041830 02H303 08/30/06; 041830 02H304 08/30/06; 041830 02H305 08/30/06; 041830 02H306 08/30/06; 041830 02H307 08/30/06; 041830 02H308 08/30/06; 041830 02K032 10/30/06; 041830 02K033 10/30/06; 041830 02K034 10/30/06; 041830 02K035 10/30/06; 041830 02K036 10/30/06; 041830 02K501 10/30/06; 041830 02K502 10/30/06; 041830 02K503 10/30/06; 041830 02K504 10/30/06; 041830 02K505 10/30/06; 041830 02M220 11/28/06; 041830 02M223 11/28/06; 041830 02M377 11/28/06; 041830 02N341 01/31/07; 041830 02N342 01/31/07; 041830 02N343 01/31/07; 041830 02N344 01/31/07; 041830 02N345 01/31/07; 041830 03A495 01/31/07; 041830 03A496 01/31/07; 041830 03A497 01/31/07; 041830 03A498 01/31/07; 041830 03A499 01/31/07; 041830 3B28N 05/31/06; 041830 3C03N 05/31/06; 041830 3C03N1 05/31/06; 041830 3C04N 05/31/06; 041830 3E21N 05/31/06; 041830B 03E184 05/31/07; 041830B 03E185 05/31/07; 041830B 03E186 05/31/07; 041830B 03E187 05/31/07; 041830B 03E188 05/31/07; 041830B 03E189 05/31/07; 041830B 03E306 06/30/07; 041830B 03E307 06/30/07; 041830B 03E308 06/30/07; 041830B 03E309 06/30/07; 041830B 03E310 06/30/07; 041830B 03E311 06/30/07; 041830B 03E312 06/30/07; 041830B 03E313 06/30/07; 041830B 03E314 06/30/07; 041830B 03E315 06/30/07; 041830B 03E316 06/30/07; 041830B 03E317 06/30/07; 041830B 03G148 06/30/07; 041830B 03G149 06/30/07; 041830B 03G150 07/31/07; 041830B 03G151 07/31/07; 041830B 03G152 07/31/07; 041830B 03G153 07/31/07; 041830B 03H161 09/30/07; 041830B 03H162 09/30/07; 041830B 03H165 09/30/07; 041830B 03K146 10/31/07; 041830B 03K147 10/31/07; 041830B 03K148 10/31/07; 041830B 03K149 10/31/07; 041830B 03K150 10/31/07; 041830B 03M125 11/30/07; 041830B 03M126 11/30/07; 041830B 03N253 11/30/07; 041830B 03N254 12/31/07; 041830B 03N255 12/31/07; 041830B 03N256 12/31/07; 041830B 04B087 02/28/08; 041830B 04B088 02/28/08; 041830B 04B089 02/28/08; 041830B 04B090 02/28/08; 041830B 04D185 04/30/08; 041830B 04D186 04/30/08; 041830B 04D187 04/30/08; 041830B 04D188 04/30/08; 041830B 04D189 04/30/08; 041830B 04F244 05/31/08; 041830B 04F245 05/31/08; 041830B 04F246 05/31/08; 041830B 04F247 06/30/08; 041830B 04F248 06/30/08; 041830B 04F249 06/30/08; 041830B 04F250 06/30/08; 041830B 04F251 06/30/08; 041830B 04F252 06/30/08; 041830B 04F253 06/30/08; 041830B 04F254 06/30/08; 041830B 04F255 06/30/08; 041830B 04F256 06/30/08; 041830B 04F257 06/30/08; 041830B 04F258 06/30/08; 041830B 04H237 09/30/08; 041830B 04H238 09/30/08; 041830B 04H239 09/30/08; 041830B 04H240 09/30/08; 041830B 04H241 09/30/08; 041830B 04H242 09/30/08; 041830B 04H243 09/30/08; 041830B 04K124 10/31/08; 041830B 04K125 10/31/08; 041830B 04K126 10/31/08; 041830B 04K127 10/31/08; 041830B 04K128 10/31/08; 041830B 04K129 10/31/08; 041830B 04K130 10/31/08; 041830B 04N108 12/31/08; 041830B 04N109 12/31/08; 041830B 04N110 12/31/08; 041830B 04N111 12/31/08; 041830B 04N112 12/31/08; 041830B 04N113 12/31/08; 041830B 04N266 12/31/08; 041830B 05B160 03/31/09; 041830B 05B161 03/31/09; 041830B 05B162 03/31/09; 041830B 05B163 03/31/09; 041830B 05B164 03/31/09; 041830B 05D067 04/30/09; 041830B 05D068 04/30/09; 041830B 05D069 04/30/09; 041830B 05D070 04/30/09; 041830B 05D071 04/30/09; 041830B 05D072 04/30/09; 041830B 05D073 04/30/09; 041830B 05D074 04/30/09; 041830B 05D075 04/30/09; 041830B 05D076 04/30/09; 041830B 05E047 06/30/09; 041830B 05E048 06/30/09; 041830B 05E049 06/30/09; 041830B 05E067 06/30/09; 041830B 05E068 06/30/09; 041830B 05E069 06/30/09; 041830B 05F055 07/31/09; 041830B 05F056 07/31/09; 041830B 05F057 07/31/09; 041830B 05F058 07/31/09; 041830B 05F059 07/31/09; 041830B 05G038 07/31/09; 041830B 05G039 07/31/09; 041830B 05G040 07/31/09; 041830B 05G041 07/31/09; 041830B 05G137 07/31/09; 041830B 05H075 09/30/09; 041830B 05H076 09/30/09; 041830B 05H077 09/30/09; 041830B 05H078 09/30/09; 041830B 05H079 09/30/09; 041830B 05H080 09/30/09; 041830B 05H081 09/30/09; 041830B 05H082 09/30/09; 041830B 05K045 04/30/09; 041830B 05K046 10/31/09; 041830B 05K047 10/31/09; 041830B 05K048 10/31/09; 041830B 05K049 10/31/09; 041830B 05K050 10/31/09; 041830B 05K273 10/31/09; 041830B 05K274 10/31/09; 041830B 05M061 11/30/09; 041830B 05M062 11/30/09; 041830B 05M063 12/31/09; 041830B 05N059 01/31/10; 041830B 05N060 01/31/10; 041830B 05N061 01/31/10; 041830B 05N062 01/31/10; 041830B 3B26C 10/31/06; 041830B 3B26CA 10/31/06; 041830B 3C05C 11/28/06; 041830B 3C05CA 11/28/06; 041830B 3E05N 01/31/07; 041830B 3H05N 05/31/06; 041830B 3K11N 05/31/06; 041830B 3K14N 05/31/06; 041830B 4H09N 09/30/07; 041830B 4H09N1 07/31/07; 041830B 4H10N 07/31/07; 041830B 4H12N 07/31/07; 041830B 4L03N 09/30/07; 041830B 4L03N1 09/30/07; 041830B 4L06N 09/30/07; 041830B 4L09N 09/30/07; Citrucel Orange with free 6 ct. caplet sample: 041833 2E07N 02/28/04; 041833 2E08N 02/28/04; 041833 2E09N 02/28/04; 041833 2E09N1 02/28/04; 041833 2F13N 02/28/04; 041833 2L11N 02/28/04; 041833 2L11N1 06/30/04; 041833 2L12N 06/30/04; 041833 2L12N1 06/30/04; 041833 2L13N 06/30/04; 041833 2L13N1 06/30/04; Citrucel Orange with free Pedometer: 041834 3E30N 11/30/06; 041834 3F04N 11/28/06; 041834 3F04N1 11/28/06; 041834 3F05N 01/31/07; 041834 3F06N 01/31/07; 041834 3F06N1 01/31/07; 041834 3F09N 01/31/07; 041834 3F10N 01/31/07; 041834 3F10N1 01/31/07; 041834 3F10N2 01/31/07; 041834 3F11N 01/31/07; 041834 3F11N1 01/31/07; 041834 3F11N2 01/31/07; 041834 3F12N 01/31/07; 041834 3F12N1 01/31/07; 041834 3F12N2 01/31/07; 041834 3F13N 01/31/07; 041834 3F24N 01/31/07; 041834 3F24N1 01/31/07; 041834 3F25N 01/31/07; 041834 3F27N 01/31/07; 041850 02F469 06/30/06; Citrucel Reg Powder 65 oz: 041850 02F470 06/30/06; 041850 02F471 06/30/06; 041850 02F472 06/30/06; 041850 02H315 09/30/06; 041850 02H316 09/30/06; 041850 02H317 09/30/06; 041850 02H318 09/30/06; 041850 02M205 11/30/06; 041850 02M206 11/30/06; 041850 02M207 11/30/06; 041850 02M208 11/30/06; 041850 02N337 01/31/07; 041850 02N338 01/31/07; 041850 02N339 01/31/07; 041850 02N340 01/31/07; 041850 03A508 01/31/07; 041850 03A509 01/31/07; 041850 03A510 01/31/07; 041850 03A511 01/31/07; 041850 03B246 02/28/07; 041850 03B247 02/28/07; 041850 03B248 02/28/07; 041850 03B249 02/28/07; 041850 03E305 06/30/07; 041850 03G146 06/30/07; 041850 03G147 06/30/07; 041850 03H166 09/30/07; 041850 03M124 11/30/07; 041850 03N257 12/31/07; 041850 04B091 02/28/08; 041850 04B092 02/28/08; 041850 04B093 02/28/08; 041850 04D190 04/30/08; 041850 04D191 04/30/08; 041850 04D192 04/30/08; 041850 04D193 04/30/08; 041850 04D194 04/30/08; 041850 04E386 05/31/08; 041850 04E387 05/31/08; 041850 04H235 09/30/08; 041850 04H236 09/30/08; 041850 04K122 10/31/08; 041850 04K123 10/31/08; 041850 04N106 12/31/08; 041850 04N107 12/31/08; 041850 05B159 03/31/09; 041850 05C067 04/30/09; 041850 05C068 04/30/09; 041850 05C069 04/30/09; 041850 05C070 04/30/09; 041850 05E045 06/30/09; 041850 05E046 06/30/09; 041850 05F053 07/31/09; 041850 05F054 07/31/09; 041850 05H013 08/31/09; 041850 05H014 08/31/09; 041850 05H015 08/31/09; 041850 05J033 09/30/09; 041850 05J034 09/30/09; 041850 05J279 09/30/09; 041850 05M059 12/31/09; 041850 05M060 12/31/09; 041850 05M158 12/31/09; 041850 05M159 12/31/09; 041850 3B26N 08/23/04; 041850 3B26N1 08/23/04; 041850 3B26N2 11/30/04; 041850 3B27N 12/31/04; 041850 3B27N1 02/28/05; 041850 3B27N2 02/28/05; 041850 3B27N3 02/28/05; 041850 3B28N 02/28/05; 041850 3B28N1 02/28/05; 041850 3B28N2 02/28/05; 041850 3B28N3 02/28/05; 041850 3B28N4 02/28/05; 041850 3B28N5 06/30/05; 041850 3C03N 08/31/05; 041850 3C24N 08/30/05; 041850 3C28N 05/31/05; 041850 3C28N1 06/30/05; 041850 3C28N2 10/31/05; 041850 3C28N3 10/31/05; 041850 3C28N4 10/31/05; 041850 3E20N 10/31/05; 041850 3E20N1 10/31/05; 041850 3E20N2 10/31/05; 041850 3E20N3 06/30/06; 041850 3E20N4 01/31/06; 041850 3H06N 01/31/06; 041850 3H06N1 06/30/06; Citrucel Powder/Caplets: 042016 2E08N 03/31/04; 042016 2E29N 04/30/04; 042016 2F05N 04/30/04; 042016 2G12N 05/31/04; 042016 2H02N 05/31/04; 042016 2H16N 05/31/04; 042016 2H19N 06/30/04; Citrucel Mixed PDQ Display: 042060 2I16N 06/30/04; 042060 2I18N 06/30/04; 042060 2J07N 08/30/04; 042060 2J09N 08/30/04; 042060 2J10N 08/31/04; 042060 2L03N 10/30/04; 042060 2L04N 10/30/04; 042060 3A28N 09/30/04; 042060 3A28N1 10/31/04; 042060 3B28N 05/31/04; 042060 3C03N 05/31/04; 042060 3C03N1 05/31/04; 042060 3C04N 06/30/04; 042060 3E21N 06/30/04; 042060 3E27N 12/31/04; 042060A 2K11N 03/30/03; 042060A 2K13N 03/30/03; 042060A 2K15N 03/30/03; Citrucel Mixed display Take the Challenge: 042065 3J30N 09/30/04; Citrucel 18 pc Speedpk: 042080 5E09W 02/28/07; 042080 5E12N 02/28/07; Citrucel Mixed Pallet: 042140 2K13N 08/30/05; 042140 2L09W 10/30/05; 042140 3K17N 06/30/06; 042140 3K24N 08/31/06; 042140 3K24W 10/31/06; 042140 3L08W 09/30/06; 042140 3L15W 10/31/06; 042140A 4E25N 01/31/07; 042140A 4E26N 01/31/07; 042140A 4K16N 09/30/07; 042140A 4L06N 11/30/07; 042140A 4L07N 11/30/07; 042140A 4L08N 10/31/07; Citrucel Powder Mix Pallet: 042144 5L09N 09/30/09; 042144 5L10N 06/30/09; 042144 5L12N 09/30/09; Citrucel Sidekick: 042145 2K21N 03/30/03; 042145 2K26N 03/30/03; 042145 3A30N 03/30/03; 042145 3K12N 09/30/04; 042145 3K12N1 09/30/04; 042145 3K26N 09/30/04; 042145 3L02N 09/30/04; 042145 3L04N 09/30/04; Citrucel Mix 18pc End Cap: 044350 5K28N 03/31/08; 044350 5K29N 03/31/08; 044350 5K29N1 03/31/08; 044350 5K30N 03/31/08; 044350 5K30N1 03/31/08; 044350 5K30N2 03/31/08; 044350 5L01N 03/31/08; 044350 5L01N1 03/31/08; 044350 5L08N 03/31/08; Citrucel Reg. Powder 65 oz: 284588 02F459 06/30/06; 284588 02F460 06/30/06; 284588 02F461 06/30/06; 284588 02F462 06/30/06; 284588 02F463 06/30/06; 284588 02F464 06/30/06; 284588 02F465 06/30/06; 284588 02F466 06/30/06; 284588 02H309 09/30/06; 284588 02H310 09/30/06; 284588 02H311 09/30/06; 284588 02H312 09/30/06; 284588 02K037 11/30/06; 284588 02K038 11/30/06; 284588 02K039 11/30/06; 284588 02K040 11/30/06; 284588 03M122 11/30/07; 284588 03M123 11/30/07; 284588 04D182 04/30/08; 284588 04D183 04/30/08; 284588 04D184 04/30/08; 284588 04E384 05/31/08; 284588 04E385 05/31/08; 284588 04H234 09/30/08; 284588 04K138 06/30/08; 284588 04N099 10/31/08; 284588 04N100 10/31/08; 284588 04N101 12/31/08; 284588 05C065 04/30/09; 284588 05C066 04/30/09; 284588 05C189 04/30/09; 284588 05C190 04/30/09; 284588 05F049 06/30/09; 284588 05F050 06/30/09; 284588 05F051 06/30/09; 284588 05F052 07/31/09; 284588 05K042 10/31/09; 284588 05N140 12/31/09; 284588 05N141 12/31/09; 284588 06A064 01/31/10; 284588 06A065 01/31/10; 284588A 03E134 05/31/07; 284588A 03E196 05/31/07; 284588A 03E197 05/31/07; 284588A 03E198 05/31/07; 284588A 03F196 06/30/07; 284588A 03K142 10/31/07; 284588A 03K143 10/31/07; 284588A 03K144 10/31/07; 284588A 03K145 10/31/07; 284588A 03M122 11/30/07; 284588A 03M123 11/30/07; 284588A 03N313 10/31/07; 284588A 03N314 10/31/07; 284588A 04B094 02/28/08; 284588A 3K11N 06/30/06; 284588A 3K12N 06/30/06; 284588A 3K12N1 09/30/06; 284588A 3K12N3 09/30/06; 284588A 3K12N4 11/30/06; 284588A 3K13N 11/30/06; Citrucel Orange 65 oz with free Pedometer: 287596 3G08N 03/31/06; 287596 3G09N 06/30/06; 287596 3G10N 11/30/06; 287596 3G11N 11/30/06; 287596 3G11N1 11/30/06; 287596 3G14N 06/30/06;
b) All lots: Citrucel Sugar Free Powder, 8.6 oz: 042009B 03D269 06/30/06; 042009B 03D270 06/30/06; 042009B 03E268 06/30/06; 042009B 03E410 06/30/06; 042009B 03G159 08/31/06; 042009B 03H152 09/30/06; 042009B 03H153 09/30/06; 042009B 03K161 10/31/06; 042009B 03N267 02/28/07; 042009B 03N268 02/28/07; 042009B 04C041 02/28/07; 042009B 04C041A 02/28/07; 042009B 04G234 07/31/07; 042009B 04G235 07/31/07; 042009B 04G236 07/31/07; 042009B 04G237 07/31/07; 042009B 04K139 11/30/07; 042009B 04K140 11/30/07; 042009B 04K395 11/30/07; 042009B 04N117 11/30/07; 042009B 04N118 12/31/07; 042009B 04N319 11/30/07; 042009B 05A286 12/31/07; 042009B 05C045 03/31/08; 042009B 05D100 05/31/08; 042009B 05D101 05/31/08; 042009B 05G044 07/31/09; 042009B 05G045 07/31/09; 042009B 05J044 10/30/09; 042009B 05J113 08/31/09; 042009B 05K040 10/31/09; 042009B 05M156 01/31/10; 042009B 05M157 01/31/10; Citrucel Sugar Free Powder 16.9 oz: 042017B 03D263 05/31/06; 042017B 03D264 05/31/06; 042017B 03D265 05/31/06; 042017B 03D266 05/31/06; 042017B 03D267 05/31/06; 042017B 03D268 05/31/06; 042017B 03E269 06/30/06; 042017B 03E270 06/30/06; 042017B 03E271 06/30/06; 042017B 03F186 06/30/06; 042017B 03F187 06/30/06; 042017B 03F188 06/30/06; 042017B 03F189 06/30/06; 042017B 03F190 06/30/06; 042017B 03F191 06/30/06; 042017B 03G160 08/31/06; 042017B 03G161 08/31/06; 042017B 03G162 08/31/06; 042017B 03G163 08/31/06; 042017B 03H149 08/31/06; 042017B 03H150 08/31/06; 042017B 03H151 08/31/06; 042017B 03K124 10/31/06; 042017B 03K136 10/31/06; 042017B 03K137 10/31/06; 042017B 03K138 10/31/06; 042017B 03K139 10/31/06; 042017B 03K140 10/31/06; 042017B 03M065 11/30/06; 042017B 03M110 11/30/06; 042017B 03M111 11/30/06; 042017B 03M112 11/30/06; 042017B 03M113 11/30/06; 042017B 03M114 01/31/07; 042017B 03M115 01/31/07; 042017B 03M116 01/31/07; 042017B 03M117 01/31/07; 042017B 04A287 01/31/07; 042017B 04A288 01/31/07; 042017B 04A289 01/31/07; 042017B 04A290 01/31/07; 042017B 04C039 02/28/07; 042017B 04C040 02/28/07; 042017B 04E259 06/30/07; 042017B 04E260 06/30/07; 042017B 04E261 06/30/07; 042017B 04E262 05/31/07; 042017B 04E263 05/31/07; 042017B 04E264 05/31/07; 042017B 04E265 05/31/07; 042017B 04E266 05/31/07; 042017B 04E267 05/30/07; 042017B 04E268 05/30/07; 042017B 04G142 05/31/07; 042017B 04G143 05/31/07; 042017B 04G144 05/31/07; 042017B 04G145 06/30/07; 042017B 04G146 06/30/07; 042017B 04G147 06/30/07; 042017B 04G148 06/30/07; 042017B 04G149 06/30/07; 042017B 04G407 02/28/07; 042017B 04G408 02/28/07; 042017B 04H229 07/31/07; 042017B 04H230 07/31/07; 042017B 04H231 08/31/07; 042017B 04H232 08/31/07; 042017B 04J355 09/30/07; 042017B 04J356 09/30/07; 042017B 04J357 09/30/07; 042017B 04J358 09/30/07; 042017B 04K141 11/30/07; 042017B 04K142 11/30/07; 042017B 04K143 11/30/07; 042017B 04K144 11/30/07; 042017B 04K145 11/30/07; 042017B 04K146 11/30/07; 042017B 04M186 11/30/07; 042017B 04M187 11/30/07; 042017B 04M188 11/30/07; 042017B 04M189 11/30/07; 042017B 04M190 11/30/07; 042017B 04N114 12/31/07; 042017B 04N115 12/31/07; 042017B 04N116 12/31/07; 042017B 05A285 12/31/07; 042017B 05C046 03/31/08; 042017B 05C047 03/31/08; 042017B 05C048 03/31/08; 042017B 05C049 03/31/08; 042017B 05C050 03/31/08; 042017B 05C051 03/31/08; 042017B 05D084 03/31/08; 042017B 05D085 03/31/08; 042017B 05D086 05/31/08; 042017B 05D087 05/31/08; 042017B 05D088 05/31/08; 042017B 05D089 05/31/08; 042017B 05E053 06/30/08; 042017B 05E054 06/30/08; 042017B 05E055 06/30/08; 042017B 05E056 06/30/08; 042017B 05E099 06/30/08; 042017B 05E100 06/30/08; 042017B 05E101 06/30/08; 042017B 05E102 06/30/08; 042017B 05G046 07/31/09; 042017B 05G047 07/31/09; 042017B 05G089 07/31/09; 042017B 05G090 07/31/09; 042017B 05G091 07/31/09; 042017B 05G092 07/31/09; 042017B 05H024 08/31/09; 042017B 05H025 08/31/09; 042017B 05H026 08/31/09; 042017B 05J040 10/31/09; 042017B 05J041 10/31/09; 042017B 05J042 10/31/09; 042017B 05J043 10/31/09; 042017B 05M047 10/31/09; 042017B 05M048 10/31/09; 042017B 05M049 10/31/09; 042017B 05M050 10/31/09; 042017B 05M051 10/31/09; 042017B 05M052 10/31/09; 042017B 05M053 10/31/09; 042017B 05M054 10/31/09; 042017B 05M149 10/31/09; 042017B 05M150 11/30/09; 042017B 05N054 01/31/10; 042017B 05N055 01/31/10; 042017B 05N056 01/31/10; 042017B 06A072 01/31/10; 042017B 3E01N 11/30/05; 042017B 3H05N 05/31/05; 042017B 3K12N 05/31/05; 042017B 3K13N 05/31/05; 042017B 4J06N 08/31/06; 042017B 4J06N1 08/31/06; 042017B 4J07N 08/31/06; 042017B 4J07N1 10/31/06; 042017B 4J08N 10/31/06; 042017B 4J10N 10/31/06; 042017B 4L03N 08/31/06; 042017B 4L06N 08/31/06; 042017B 4L06N1 08/31/06; Citrucel Sugar Free with Free Pedometer: 042021 3F24N1 05/31/06; 042021 3F25N 05/31/06; 042021 3F26N 05/31/06; 042021 3F26N1 08/31/05; 042021 3G16N 05/31/06; 042021 3G16N1 05/31/06; 042021 3G18N 05/31/06; 042021 3G18N1 06/30/06; 042021 3G18N2 06/30/06; 042021 3G21N 06/30/06; Citrucel Sugar Free Orange Conv. Pack: 042025 03D257 05/31/06; 042025 03D258 05/31/06; 042025 03J244 09/30/06; 042025 03J245 09/30/06; 042025 03K163 10/31/06; 042025 03K164 10/31/06; 042025 03K165 10/31/06; 042025 03K166 10/31/06; 042025 03K167 10/31/06; 042025 03N315 01/31/07; 042025 03N316 01/31/07; 042025 04B254 02/28/07; 042025 04B255 02/28/07; 042025 04B256 02/28/07; 042025 04B257 02/28/07; 042025 04E139 05/31/07; 042025 04E140 05/31/07; 042025 04E141 05/31/07; 042025 04G026 08/31/07; 042025 04G027 08/31/07; 042025 04N097 12/31/07; 042025 04N098 01/31/08; 042025 04N124 01/31/08; 042025 04N125 01/31/08; 042025 04N126 01/31/08; 042025 04N263 01/31/08; 042025 05C153 03/31/08; 042025 5B02N 09/30/07; Citrucel Sugar Free Orange - 1 dose packet: 042040 04B258 02/28/07; 042040 04E137 05/31/07; 042040 04E138 05/31/07; 042040 04H367 09/30/07; 042040 04H368 09/30/07; 042040 04N264 01/31/08; 042040 05C152 03/31/08; Citrucel Sugar Free Powder, 32 oz: 042050 03D261 05/31/06; 042050 03D262 05/31/06; 042050 03E229 06/30/06; 042050 03G164 08/31/06; 042050 03G165 08/31/06; 042050 03G166 08/31/06; 042050 03G167 08/31/06; 042050 03H146 08/31/06; 042050 03H147 08/31/06; 042050 03H148 08/31/06; 042050 03K125 10/31/06; 042050 03K126 10/31/06; 042050 03K127 10/31/06; 042050 03K128 10/31/06; 042050 03K129 10/31/06; 042050 03K154 10/31/06; 042050 03K155 10/31/06; 042050 03M105 11/30/06; 042050 03M106 11/30/06; 042050 03M107 11/30/06; 042050 03M108 11/30/06; 042050 03M109 11/30/06; 042050 04A299 02/28/07; 042050 04A300 02/28/07; 042050 04C036 02/28/07; 042050 04C037 02/28/07; 042050 04C038 02/28/07; 042050 04E254 11/30/06; 042050 04E255 11/30/06; 042050 04E256 11/30/06; 042050 04E257 11/30/06; 042050 04E258 05/31/07; 042050 04G135 07/31/07; 042050 04G136 07/31/07; 042050 04G137 07/31/07; 042050 04G138 07/31/07; 042050 04G233 07/31/07; 042050 04H222 08/31/07; 042050 04H223 08/31/07; 042050 04H224 08/31/07; 042050 04H225 08/31/07; 042050 04H226 08/31/07; 042050 04H227 09/30/07; 042050 04H228 09/30/07; 042050 04J348 09/30/07; 042050 04J349 09/30/07; 042050 04J350 09/30/07; 042050 04J351 09/30/07; 042050 04J352 09/30/07; 042050 04J353 09/30/07; 042050 04J354 09/30/07; 042050 04M011 11/30/07; 042050 04M012 11/30/07; 042050 04M013 11/30/07; 042050 04M014 11/30/07; 042050 04M015 11/30/07; 042050 04M016 11/30/07; 042050 04M017 11/30/07; 042050 04M018 11/30/07; 042050 04M019 11/30/07; 042050 04N120 12/31/07; 042050 04N267 12/31/07; 042050 05C052 03/31/08; 042050 05C053 03/31/08; 042050 05C054 03/31/08; 042050 05C055 03/31/08; 042050 05C056 03/31/08; 042050 05C057 03/31/08; 042050 05C058 03/31/08; 042050 05D097 05/31/08; 042050 05D098 05/31/08; 042050 05D099 05/31/08; 042050 05E057 06/30/08; 042050 05E058 06/30/08; 042050 05E059 06/30/08; 042050 05E060 06/30/08; 042050 05E103 06/30/08; 042050 05E104 06/30/08; 042050 05G048 07/31/09; 042050 05G049 07/31/09; 042050 05G050 07/31/09; 042050 05H021 08/31/09; 042050 05H022 08/31/09; 042050 05H023 08/31/09; 042050 05H341 07/31/09; 042050 05J037 09/30/09; 042050 05J038 09/30/09; 042050 05J039 09/30/09; 042050 05K036 09/30/09; 042050 05K037 09/30/09; 042050 05K038 09/30/09; 042050 05K039 09/30/09; 042050 05M055 11/30/09; 042050 05M056 11/30/09; 042050 05M057 11/30/09; 042050 05M058 11/30/09; 042050 05N051 08/31/09; 042050 05N052 08/31/09; 042050 05N053 10/31/09; 042050 06A069 01/31/10; 042050 06A071 01/31/10; 042050 3C26N 04/30/04; 042050 3C26N1 04/30/04; 042050 3C26N2 07/30/04; 042050 3C26N3 07/30/04; 042050 3C26N4 07/31/04; Citrucel Sugar Free Powder, 42 oz: 287589 03D259 05/31/06; 287589 03M119 11/30/06; 287589 03M120 11/30/06; 287589 03M121 11/30/06; 287589 04E244 05/31/07; 287589 04E245 05/31/07; 287589 04E246 05/31/07; 287589 04E247 05/31/07; 287589 04E248 05/31/07; 287589 04E249 05/31/07; 287589 04E250 05/31/07; 287589 04E251 05/31/07; 287589 04E252 05/31/07; 287589 04E253 05/31/07; 287589 04G127 07/31/07; 287589 04G128 07/31/07; 287589 04G129 07/31/07; 287589 04G130 07/31/07; 287589 04H218 08/31/07; 287589 04H219 08/31/07; 287589 04H220 08/31/07; 287589 04H221 08/31/07; 287589 04H534 09/30/07; 287589 04H535 09/30/07; 287589 04J346 09/30/07; 287589 04J347 09/30/07; 287589 04K257 10/31/07; 287589 04K258 10/31/07; 287589 04K259 10/31/07; 287589 04K260 11/30/07; 287589 04K261 10/31/07; 287589 04K262 11/30/07; 287589 04N121 12/31/07; 287589 04N122 12/31/07; 287589 04N123 12/31/07; 287589 04N288 09/30/07; 287589 05C059 01/31/08; 287589 05C060 03/31/08; 287589 05C061 03/31/08; 287589 05C062 03/31/08; 287589 05C063 03/31/08; 287589 05C064 03/31/08; 287589 05C185 03/31/08; 287589 05C186 03/31/08; 287589 05C187 03/31/08; 287589 05C188 03/20/08; 287589 05D090 05/31/08; 287589 05D091 05/31/08; 287589 05D092 05/31/08; 287589 05D093 05/31/08; 287589 05D094 05/31/08; 287589 05D095 05/31/08; 287589 05D096 05/31/08; 287589 05E061 06/30/08; 287589 05E062 06/30/08; 287589 05E063 06/30/09; 287589 05E064 06/30/09; 287589 05E105 06/30/09; 287589 05G051 07/31/09; 287589 05G052 07/31/09; 287589 05G053 07/31/09; 287589 05G054 07/31/09; 287589 05G055 07/31/09; 287589 05G056 07/31/09; 287589 05J035 09/30/09; 287589 05J083 09/30/09; 287589 05J085 09/30/09; 287589 05J086 09/30/09; 287589 05J087 09/30/09; 287589 05M151 11/30/09; 287589 05M152 11/30/09; 287589 05M153 11/30/09; 287589 05M154 12/31/09; 287589 05M155 12/31/09; 287589 05N142 12/31/09; 287589 05N193 12/31/09; 287589 05N194 12/31/09; 287589 06A066 11/30/09; 287589 06A067 11/30/09; 287589 06A068 12/31/09; 287589 06A351 01/31/10; 287589 4D26W 01/31/07; 287589 4D27W 01/31/07; 287589A 03E223 05/31/06; 287589A 03E224 05/31/06; 287589A 03E225 06/30/06; 287589A 03E226 06/30/06; 287589A 03E227 06/30/06; 287589A 03E411 06/30/06; 287589A 03H276 08/31/06; 287589A 03H277 08/31/06; 287589A 03H278 08/31/06; 287589A 03H279 08/31/06; 287589A 03K130 10/31/06; 287589A 03K131 10/31/06; 287589A 03K132 10/31/06; 287589A 03K133 10/31/06; 287589A 03K134 10/31/06; 287589A 03K135 10/31/06; 287589A 03M103 10/30/06; 287589A 03M104 10/31/06; 287589A 03M118 11/30/06; 287589A 03M119 11/30/06; 287589A 04A291 01/31/07; 287589A 04A292 01/31/07; 287589A 04A293 01/31/07; 287589A 04A294 01/31/07; 287589A 04A295 01/31/07; 287589A 04A296 01/31/07; 287589A 04A297 01/31/07; 287589A 04A298 01/31/07; 287589A 04C035 02/28/07; Citrucel Sugar Free 42 oz with Pedometer: 287595 3G09N 02/28/06; 287595 3G09N1 05/31/06; 287595 3G10N 05/31/06; 287595 3G11N 05/31/06; 287595 3G11N1 06/30/05; 287595 3H14N 06/30/05; 287595 3H15N 06/30/06; 287595 3H20N 05/31/06; 287595 3H29N 05/31/06; 287595 3H29N1 05/31/06; 287595 3H29N2 06/30/06; 287595 3I02N 06/30/06; 287595 3I02N1 06/30/06
RECALLING FIRM/MANUFACTURER
Recalling Firm: GlaxoSmithKline Consumer Healthcare, Parsippany, NJ, by letters on May 19, 2006 and May 31, 2006.
Manufacturer: ICL Performance Products LP, St. Louis, MO. Firm initiated recall is ongoing.
REASON
Presence of foreign substances; small, semi-flexible metal wire detected.
VOLUME OF PRODUCT IN COMMERCE
10,296,304 canisters/2,786,105 pouches
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Nicotine Polarcrilex Gum, 4 mg (nicotine), original flavor, OTC, packaged in blister strip packages of 110 or 170 pieces per package under the Walmart Equate (NDC 49035-170-25) and the Major Nicorelief (NDC 0904-5735-11) brand names, Recall # D-263-6
CODE
Lot numbers: 6CE0606 and 6CE0810
RECALLING FIRM/MANUFACTURER
Recalling Firm: Perrigo Company, Allegan, MI, by letter on May 23, 2006.
Manufacturer: Fertin Pharma A/S, Allegan, MI. Firm initiated recall is ongoing.
REASON
Mislabeling: Some of the foil packs inside the carton are mislabeled with as 2 mg., when the strength is actually 4 mg.
VOLUME OF PRODUCT IN COMMERCE
2,448 packages
DISTRIBUTION
Nationwide
 

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III

______________________________
PRODUCT
Potassium PHOSphate 15 mMol in 0.9% Sodium Chloride, 250mL, Flexible Plastic Bag. For Intravenous Use. Product Order Number: Q3045, Recall # D-260-6
CODE
Lot number: MP002445, Exp. 5/1/2006
RECALLING FIRM/MANUFACTURER
Solunet LLC, Totowa, NJ, by telephone on April 7, 2006. Firm initiated recall is complete.
REASON
Mislabeled; product label inadvertently placed on flexible plastic bag labeled as containing 5% Dextrose.
VOLUME OF PRODUCT IN COMMERCE
50 bags
DISTRIBUTION
CT

______________________________
PRODUCT
Acetaminophen Caplets, 650 mg, OTC, 50 caplets, packaged under the following brand names: Para-X-Dolor, Tyle-Dolor, Dolofin Forte, Pain-Eze + and Calma Dolor (Extra Fuerte), Recall # D-264-6
CODE
Lot 053084, Exp. 11/08; A6550, Exp. 110805
RECALLING FIRM/MANUFACTURER
Recalling Firm: Reese Pharmaceutical Co., Cleveland, OH, by letter, dated June 5, 2006.
Manufacturer: Contract Pharmacal Corp., Hauppauge, NY. Firm initiated recall is ongoing.
REASON
Mislabeling: The product contains an incorrect expiration date of 11/08. The correct expiration date is 1/08.
VOLUME OF PRODUCT IN COMMERCE
620/50 caplet bottles
DISTRIBUTION
Nationwide

______________________________

PRODUCT
Ketoprofen extended-release capsules, light turquoise blue capsule, light turquoise blue body, imprinted with "Andrx 520" and "200 mg". Rx only, Recall # D-265-6
CODE
Lot Numbers: 520E017B, 520E018A, F520F0840A, F520F1030A, F520F1031A and F520F0368A
RECALLING FIRM/MANUFACTURER
Andrx Pharmaceuticals, Inc, Davie, FL, by letters on March 24, 2006. Firm initiated recall is ongoing.
REASON
CGMP Deviations: Andrx mis-identified the manufacture of these lots as validation, when they were study lots. The manufactured lots deviated from the master batch record instructions.
VOLUME OF PRODUCT IN COMMERCE
3,245,400 tablets
DISTRIBUTION
Nationwide

______________________________
PRODUCT
a) Westcort® (hydrocortisone valerate) Cream, 0.2%, in 15 gram, 45 gram, & 60 gram
tubes, Rx only.
Product labeled as follows: --- Westcort® (hydrocortisone valerate) Cream, 0.2%,
NET Wt. 15 g,
WESTWOOD SQUIBB™, Rx only, NDC 00072-8100-15, NSN 6505-01-093-9901,
BMS Item No. 8100-15 ---
Westcort® (hydrocortisone valerate) Cream, 0.2%, NET Wt. 45 g, WESTWOOD
SQUIBB™, Rx only, NDC 00072-8100-45, NSN 6505-01-083-9395, BMS Item No.
8100-45 ---
Westcort® (hydrocortisone valerate) Cream, 0.2%, NET Wt. 60 g, WESTWOOD
SQUIBB™, Rx only, NDC 00072-8100-60, NSN6505-01-121-0118, BMS Item No.
8100-60, Recall # D-267-6;
b) Hydrocortisone Valerate Cream 0.2% (generic) in 15 gram, 45 gram, and 60 gram
tubes, Rx only. The product is labeled as follows:
15 g tube: NDC 59772-8100-7, BMS Item No. 810070, Hydrocortisone Valerate
Cream 0.2%, NET WT. 15 g, Rx only, APOTHECON® ---
45 g tube: NDC 59772-8100-4, BMS Item No. 810040, Hydrocortisone Valerate
Cream 0.2%, NET WT. 45 g, Rx only, APOTHECON® --- NDC 0781-7059-19,
BMS Item No. 705919, Hydrocortisone Valerate Cream 0.2%, Rx only, SANDOZ,
NET WT. 45 g, ---
60 g tube: NDC 59772-8100-5, BMS Item No. 810050, Hydrocortisone Valerate
Cream 0.2%, NET WT. 60 g, Rx only, APOTHECON® --- NDC 0781-7059-35,
BMS Item No. 705935, Hydrocortisone Valerate Cream 0.2%, Rx only, SANDOZ,
NET WT. 60 g, Recall # D-268-6
CODE
a) 15 g tube: Lots 81T013 (exp. date 7/06), 81U008 (exp. date 8/07), and 81U011
(exp. date 11/07) ---
45 g tube: Lots 81T018 (exp. date 9/06), 81U008 (exp. date 8/07), and 81W010
(exp. date 6/08) ---
60 g tube: Lots 81T015 (exp. date 9/06) and 81W010 (exp. date 6/08);
b) 15 g tube: Lot 81W001 (exp. date 1/08). ---
45 g tube: Lots 81U002 (exp. date 3/07) and 81U006 (exp. date 5/07); Lot 81W011
(exp. date 6/08) ---
60 g tube: Lots 81T014 (exp. date 9/06), 81U005 (exp. date 5/07), and 81W002
(exp. date 1/08),
Lot 81W012 (exp. date 6/08)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bristol-Myers Squibb Company, New Brunswick, NJ, by Urgent Drug Recall packages on June 1, 2006.
Manufacturer: Contract Pharmaceuticals Limited Niagara, Buffalo, NY. Firm initiated recall is ongoing.
REASON
SUBPOTENT: Some lots did not meet the specification for hydrocortisone-17 valerate throughout the labeled shelf life of the product.
VOLUME OF PRODUCT IN COMMERCE
353,796 tubes
DISTRIBUTION
Nationwide
 

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

______________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1215-6
CODE
Unit number: 12FL13018
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Charlotte, NC, by letter dated August 6, 2002. Firm initiated recall is complete.
REASON
Blood product, which did not meet acceptable product specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC

______________________________
PRODUCT
Source Plasma, Recall # B-1216-6
CODE
Unit numbers: 10047335, 10047768, 10047926, 10048213, 10048359, 10048760, 10048807, 10049216, 10049269, 10049722, 10049817, 10050153, 10050219, and 10051163
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Allentown, PA, by facsimile on September 20, 2005. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had a history of drug use, were distributed.
VOLUME OF PRODUCT IN COMMERCE
14 units
DISTRIBUTION
Spain

______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1217-6
CODE
Unit numbers: 2604515 and 2563383
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on September 28, 2004. Firm initiated recall is ongoing.
REASON
Blood products, which were collected from a donor who had traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX

______________________________
PRODUCT
a) Platelets, Recall # B-1218-6;
b) Fresh Frozen Plasma, Recall # B-1219-6
CODE
a) and b) Unit number: LF69250
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA, by facsimile on December 12, 2005. Firm initiated recall is complete.
REASON
Blood products, which were manufactured from a whole blood unit in which the associated blood product contained clots, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
PA

______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Irradiated, Recall # B-1313-6
CODE
Unit number: 03KR13784
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southern Region, Atlanta, GA, by telephone on April 7, 2004. Firm initiated recall is complete.
REASON
Blood product, which yielded a platelet count that was below the acceptable limit, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA

______________________________
PRODUCT
Plasma, Cryoprecipitate Reduced, Recall # B-1319-6
CODE
Unit number 0217738
RECALLING FIRM/MANUFACTURER
The Blood Connection, Inc., Greenville, SC, by telephone on August 29, 2005. Firm initiated recall is complete.
REASON
Blood product, associated with a unit of Cryoprecipitated AHF that contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
SC

______________________________
PRODUCT
a) Red Blood Cells, Recall # B-1330-6;
b) Red Blood Cells, Leukocytes Reduced, Recall # B-1331-6;
c) Red Blood Cells, Leukocytes Reduced, Irradiated, Recall # B-1332-6;
d) Platelets, Recall # B-1333-6;
e) Platelets, Leukocytes Reduced, Recall # B-1334-6;
f) Fresh Frozen Plasma, Recall # B-1335-6;
g) Plasma, Frozen, Recall # B-1336-6
CODE
a) Unit numbers: 17FZ16971, 17KF82098, 17KF86207, 17KG93289, 17KG93595,
17KH78813, 17KJ79265, 17KP65133, 17FF12329;
b) Unit numbers: 17FJ23901, 17FM01583, 17FR17537, 17FR20739, 17FW26381,
17GN14169, 17KM52907, 17KP77865, 17KP83346, 17KS19256, 17KV23215,
17KW63844, 17KY81039, 17KZ46623;
c) Unit numbers: 17KF90420, 17KW05905;
d) Unit numbers: 17FZ16971, 17KH78813
e) Unit numbers: 17FR20739, 17KM52907, 17KP83346, 17KS19256, 17KZ46623;
f) Unit numbers: 17FJ23901, 17FR17537, 17KF82098, 17KP83346, 17KS19256,
17KZ46623;
g) Unit numbers: 17KJ79265, 17KG93289
RECALLING FIRM/MANUFACTURER
American National Red Cross, North Central Region, St. Paul, MN, by telephone on November 10, 2003. Firm initiated recall is complete.
REASON
Blood products, manufactured from overweight units of Whole Blood, were distributed.
VOLUME OF PRODUCT IN COMMERCE
40 units
DISTRIBUTION
AL, CA, FL, KY, MA, MN, MS, OH, PA, and WI

______________________________
PRODUCT
a) Platelets, Recall # B-1337-6;
b) Fresh Frozen Plasma, Recall # B-1338-6
CODE
a) and b) Unit number: 107497247
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Scottsdale, AZ, by telephone on April 15, 2003. Firm initiated recall is complete.
REASON
Blood products, associated with a unit of Red Blood Cells that contained clots, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AZ
 

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

______________________________
PRODUCT
a) Red Blood Cells Pheresis, Recall # B-1210-6;
b) Red Blood Cells, Leukocytes Reduced, Recall # B-1211-6;
c) Platelets, Recall # B-1212-6;
d) Source Leukocytes, Recall # B-1213-6
CODE
a) Unit numbers: 4819506 (2 units), 4819519 (2 units), 4819525 (2 units);
b) Unit numbers: 4819522, 4819523, 4819524, 4819527, 4820732, 4838088,
4839898, 4839899, 4839900, 4839902, 4839905, 4839906, 4843778, 4843781,
4843782, 4843787, 4843790, 4843794, 4843795, 4848990, 4848991, 4848992,
4848993, 4848994, 4849114, 4856973, 4856974, 4856976, 4856979, 4856980,
4862473, 4862476, 4862483, 4862485, 4862486, 4862491, 4819526;
c) Unit numbers: 4819523, 4820732, 4839899, 4843781, 4843787, 4848990,
4848991, 4856974, 4856980, 4862472, 4862483, 4862492;
d) Unit numbers: 4817012, 4819516, 4819520, 4819521, 4819522, 4819523,
4819524, 4819526, 4819527, 4819528, 4819529, 4820732, 4838088, 4839898,
4839899, 4839900, 4839902, 4839905, 4839906, 4839907, 4843774, 4843777,
4843778, 4843781, 4843782, 4843784, 4843786, 4843787, 4843789, 4843790,
4843791, 4843792, 4843794, 4849795, 4848989, 4848990, 4848991, 4848992,
4848993, 4848994, 4848997, 4848998, 4849007, 4849008, 4849113, 4849114,
4856973, 4856974, 4856976, 4856977, 4856979, 4856980, 4862471, 4862472,
4862473, 4862474, 4862475, 4862476, 4862477, 4862478, 4862480, 4862481,
4862482, 4862483, 4862485, 4862486, 4862488, 4862489, 4862490, 4862491,
4862492, 4862493, 4856978
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by facsimile on September 22, 2004. Firm initiated recall is complete.
REASON
Blood products, which were untested for antibody to hepatitis B core antigen (anti-HBc), were distributed.
VOLUME OF PRODUCT IN COMMERCE
128 units
DISTRIBUTION
NE, NJ, and TX

______________________________
PRODUCT
Fresh Frozen Plasma, Recall # B-1214-6
CODE
Unit number: 71P353397
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Dunwoody, GA, by telephone on March 21, 2005. Firm initiated recall is complete.
REASON
Blood product, which was not manufactured within appropriate time frame after collection, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA

______________________________
PRODUCT
Red Blood Cells, Recall # B-1320-6
CODE
Unit number 0217738
RECALLING FIRM/MANUFACTURER
The Blood Connection, Inc., Greenville, SC, by telephone on August 29, 2005. Firm initiated recall is complete.
REASON
Blood product, associated with a unit of Cryoprecipitated AHF that contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
SC

______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-1321-6
CODE
Unit number: 10753-7933
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Scottsdale, AZ, by telephone on May 27, 2003. Firm initiated recall is complete.
REASON
Platelets, for which documentation of the resting time was discrepant, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AZ

______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-1339-6
CODE
Unit number: 12W41015
RECALLING FIRM/MANUFACTURER
American National Red Cross, Durham, NC, by telephone on February 15, 2000. Firm initiated recall is complete.
REASON
Blood product, which was shipped at an unacceptable temperature, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1341-6
CODE
Unit number: 2490269
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on September 8, 2003. Firm initiated recall is complete.
REASON
Blood product, labeled with the incorrect expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX

______________________________
PRODUCT
Red Blood Cells, Recall # B-1342-6
CODE
Unit number: S63048
RECALLING FIRM/MANUFACTURER
HCSC Blood Center, Bethlehem, PA, by letter on November 18, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor with an elevated temperature, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
 

 RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

______________________________
PRODUCT
a) PlusRite Power Strike Metal Halide Lamps, Recall # Z-0450-06;
b) PlusRite Low Watt Metal Halide Lamps, Recall # Z-0451-06;
c) PlusRite Universal Metal Halide Lamps, Recall # Z-0452-06;
d) PlusRite Protected Metal Halide Lamps, Recall # Z-0453-06;
e) PlusRite Mercury Vapor Lamps, Recall # Z-0454-06
CODE
N/A
RECALLING FIRM/MANUFACTURER
Fanlight Corporation Inc., City of Industry, CA, by letters on March 24, 2006. Firm initiated recall is ongoing.
REASON
The non-self-extinguishing mercury vapor and metal halide lamps failed to comply with the performance requirements of 21 CFR 1040.30 and the certification and identification requirements of 21 CFR 1010.2 and 1010.3.
VOLUME OF PRODUCT IN COMMERCE
100,000 devices
DISTRIBUTION
Nationwide

______________________________
PRODUCT
a) Aortic Perfusion Cannula with plastic tip, 22 Fr. X 28 cm Edwards
Lifesciences, REF: A3221190A, Recall # Z-1089-06;
b) Duraflow Treated Aortic Perfusion Cannula with plastic tip,
22 Fr. X 28 cm Edwards Lifesciences, REF: DARH221190TA,
Recall # Z-1090-06;
c) Aortic Perfusion Cannula with plastic tip, 22 Fr. X 28 cm Edwards
Lifesciences, REF: ARH221190TA, Recall # Z-1091-06;
d) Duraflow Treated Aortic Perfusion Cannula with plastic tip,
22 Fr. X 28 cm Edwards Lifesciences, REF: DARH221190A,
Recall # Z-1092-06;
e) Aortic Perfusion Cannula with plastic tip, 22 Fr. X 23 cm Edwards
Lifesciences, REF: AH221190A, Recall # Z-1093-06;
f) Aortic Perfusion Cannula with metal tip, 22 Fr. X 23 cm Edwards
Lifesciences, REF: MT022A, Recall # Z-1094-06;
g) Aortic Perfusion Cannula with metal tip, 22 Fr. X 23 cm Edwards
Lifesciences, REF: MT022TA, Recall # Z-1095-06
CODE
a) Lot number: 58194673;
b) Lot number: 58194842;
c) Lot numbers: 58196967, 58199178;
d) Lot number: 58198731;
e) Lot number: 58200588;
f) Lot numbers: 58209961, 58193894, 58203989, 58213564;
g) Lot numbers: 58208130, 58216517
RECALLING FIRM/MANUFACTURER
Edwards Lifesciences Research Medical, Inc., Midvale, UT, by letter and visit beginning April 18, 2006. Firm initiated recall is ongoing.
REASON
Due to potential embrittlement of the plastic tip which may crack or separate during use.
VOLUME OF PRODUCT IN COMMERCE
616 units (Domestic), 1540 units (Foreign)
DISTRIBUTION
CA, CT, FL, IN, KS, MA, MI, TN, TX, Australia, Chile, EU, India, Singapore, and Taiwan

______________________________
PRODUCT
a) Weck Hem-o-lok ML Polymer Ligating Clips; Rx, sterile, medium
large size, non-absorbable polymer ligation clips; 6 clips per cartridge,
14 cartridges per sales unit, 12 sales units per case, catalog number
544230, Recall # Z-1096-06;
b) Weck Hem-o-lok L Polymer Ligating Clips; Rx, sterile, large size,
non-absorbable polymer ligation clips; 6 clips per cartridge,
14 cartridges per sales unit, 12 sales units per case, catalog number
544240, Recall # Z-1097-06;
c) Weck Hem-o-lok XL Polymer Ligating Clips; Rx, sterile, extra large
size, non-absorbable polymer ligation clips; 6 clips per cartridge,
14 cartridges per sales unit, 12 sales units per case, catalog number
544250, Recall # Z-1098-06;
d) Weck Hem-o-lok Endo 5 Automatic Clip Applier with Medium Polymer
Ligating Clips; Rx, sterile, single use, disposable clip applier with
medium size, non-absorbable polymer ligation clips; 15 clips per applier,
3 appliers per sales unit, 6 units per case, catalog number 543965,
Recall # Z-1099-06
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teleflex Corporation, Limmerick, PA, by letters dated April 18, 2006.
Manufacturer: Teleflex Medical, Research Triangle Park, NC. Firm initiated recall is ongoing.
REASON
The Hem-o-lok ligating clips may become dislodged following ligation of the renal artery after laparoscopic donor nephrectomy. Hem-o-lok ligating clips are now contraindicated for use in ligating the renal artery during laparascopic nephrectomies in living donor patients.
VOLUME OF PRODUCT IN COMMERCE
10,458,708 clips
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Signify hCG Serum Urine 30 Test Kit, Abbott List No. 07K09-30, ABI List No. 6026KSI, Recall # Z-1100-06
CODE
Lot number: 84936, Exp. 02/10/2007
RECALLING FIRM/MANUFACTURER
Applied Biotech, Inc., San Diego, CA, by letter on May 8, 2006. Firm initiated recall is ongoing.
REASON
Certain kits from the product lot may contain test devices which contain incorrect reaction strips. Use of such devices may produce false negative results with patient samples at and above the limit of detection of the product.
VOLUME OF PRODUCT IN COMMERCE
1,198 Kits (35,940 tests)
DISTRIBUTION
IL

______________________________
PRODUCT
Heartport Direct Flow Arterial Cannula, product code DFK24. The device is sold separately and also in the following Kit Model Numbers: EDNN241, EDNN242, EDNN243, and EDNN244, Recall # Z-1101-06
CODE
Lot Numbers: MS0206031; MS0206032; MS0505014; MS0505020; MS0605009; MS0605038; MS0605039; MS0705034; MS0705035; MS0705044; MS0905040; MS0905066; MS1105041; MS1105061; MS1205043
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ethicon, Inc., Somerville, NJ, by letters on April 27, 2006.
Manufacturer: Accellent, Inc., Laconia, NH. Firm initiated recall is ongoing.
REASON
During cardiopulmonary bypass (CPB) the distal tip of the arterial cannula can become disconnected from the body of the cannula.
VOLUME OF PRODUCT IN COMMERCE
368 devices
DISTRIBUTION
Nationwide, UK and Italy

______________________________
PRODUCT
Boston Scientific Wiseguide Guide Catheter 7F, .076', Femoral Approach. Catalog number: 19500-448, Catalog number: 19500-498, Catalog number: 19500-08, Catalog number: 19500-09, Catalog number: 19500-132, Catalog number: 19500-27, Recall # Z-1102-06
CODE
Lot # 655713, L0t # 655721, L0t # 657310, L0t # 657311, L0t # 655680, L0t # 655695,
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific, Maple Grove, MN, by letter, dated May 22, 2006.
Manufacturer: Avenida Norske Edificio G1 Local B, Tijuana, Mexico. Firm initiated recall is ongoing.
REASON
Gaps were identified between polymer segments on the 7F Wiseguide Guide Catheter in which the PTFE was not properly laminated to the braid of the catheter. This delamination of the PTFE from the braid could compromise the device delivery.
VOLUME OF PRODUCT IN COMMERCE
75 devices
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Hitachi Altaire Magnetic Resonance Imaging System, Recall # Z-1103-06
CODE
L001 thru L223
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hitachi Medical Systems America, Inc., Twinsburg, OH, by letter dated January 27, 2006.
Manufacturer: Hitachi Medical Corporation, Chiyoda-Ku, Tokyo, Japan. Firm initiated recall is ongoing.
REASON
Circuit Failure -- There is the potential risk of the Phase Loss Detector Safety Device (PHSEN PCB) malfunctioning in the event of a power loss. The circuit may fail to turn off the systems main breaker when 2 of the 3 power phases are lost.
VOLUME OF PRODUCT IN COMMERCE
213 devices
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Altaire Nuclear Magnetic Resonance Imaging Device Systems, Recall # Z-1104-06
CODE
Serial Numbers: Altaire -- L217, L219, L221, L224 and L225
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hitachi Medical Systems America, Inc., Twinsburg, OH, by service technicians beginning on April 28, 2006.
Manufacturer: Hitachi Medical Corporation, Chiyoda-Ku, Tokyo, Japan. Firm initiated recall is ongoing.
REASON
Software anomaly -- A software defect can cause the slice line indicator to become mis-positioned during Multi-Planar Reconstructions (MPR) with the potential for patient mis-diagnosis.
VOLUME OF PRODUCT IN COMMERCE
5 devices
DISTRIBUTION
CO, OH, NB, and TX

______________________________
PRODUCT
MRP-7000, AIRIS Magnetic Resonance Imaging Systems, Recall # Z-1105-06
CODE
Asset Tag Numbers: 7001-7154; A007-A901; AG004-AG039
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hitachi Medical Systems America, Inc., Twinsburg, OH, by visits beginning on March 17, 2006.
Manufacturer: Hitachi Medical Corporation, Chiyoda-Ku, Tokyo, Japan. Firm initiated recall is ongoing.
REASON
Software anomaly. A software defect in the referenced systems can cause a slice indicator (reference line) to be mis-positioned on the cross-reference image when it is magnified. This image error could result in a possible patient mis-diagnosis.
VOLUME OF PRODUCT IN COMMERCE
283 devices
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Hitachi AIRIS II MRI Nuclear Magnetic Resonance Imaging System, Recall # Z-1115-06
CODE
Serial Numbers: C322 to C546; and C746 to C772
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hitachi Medical Systems America, Inc., Twinsburg, OH, by visits beginning on April 25, 2006.
Manufacturer: Hitachi Medical Corporation, Chiyoda-Ku, Tokyo, Japan. Firm initiated recall is ongoing.
REASON
Improper Assembly-The AIRIS/AIRIS II MRI system has the potential for the input wiring of a power transformer to overheat due to damaged wiring or possible loose connections.
VOLUME OF PRODUCT IN COMMERCE
248 devices
DISTRIBUTION
Nationwide

______________________________
PRODUCT
8mm SATELLITE™ Sphere CoCr contained in a SATELLITE™ Spinal System (internal fixation device-vertebral stabilization/fusion), Recall # Z-1088-06
CODE
Lot number: W05K0555
RECALLING FIRM/MANUFACTURER
Medtronic Sofamor Danek Instrument Manufacturing, Bartlett, TN, by letter on April 14, 2006. Firm initiated recall is complete.
REASON
Device marketed without 510 (k) or PMA clearance.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
LA
 

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III

______________________________
PRODUCT
a) X-Sizer Thrombectomy Catheter System (ev3) Model number
XD-CS1150-45 (for US distribution). Model number XR-CS1150-45
(for foreign distribution). 1.5mm. Sterilization with Ethylene Oxide Gas.
Recall # Z-1107-06;
b) X-Sizer Thrombectomy Catheter System (ev3) Model number
XD-CS1200-55 (for US distribution). Model number XR-CS1200-55 (for foreign distribution). 2.0mm. Sterilization with Ethylene Oxide Gas, Recall # Z-1108-06
CODE
a) Model number XD-CS1150-45 (for US distribution), lot numbers: 782344,
782345, 782366, 782379, 782386, 782389, 782403, 782404, 782406,
782407, 782412, 782421, 782428, 782429, 782430, 782436, 782438,
782439, 782441, 782445, 782526, 986604, 986604, 986604, 986605,
986609, 986620, 986626, 986640, 986641, 986642, 986645, 986656,
986659, 1174394, 1174395, 1212529, 1229730, 1231296, 1234273,
1240986, 1241067, 1271238, 1272506, 1280664, 1280952, 1281088,
1282693, 1289590, 1289978, 1293902, 1295372, 1300605, 1302005,
1303572, 1308536, 1310238, 1362165;
Model number XR-CS1150-45 (for OUS distribution), lot numbers: 782773,
782777, 782787, 782788, 782790, 782791, 782795, 782796, 782797,
782798, 782800, 782801, 782804, 782808, 782811, 782812, 782816,
782818, 782822, 782848, 987054, 987055, 987056, 987058, 987059,
987062, 987063, 987064, 987065, 987066, 987067, 987070, 987070,
987070, 987071, 987073, 987076, 987078, 1057871, 1077841, 1077842,
1077843, 1077844, 1077846, 1077847, 1077848, 1077854, 1077856,
1077859, 1077862, 1095087, 1095089, 1296437, 1296552, 1313297,
1313502, 1313543, 1313562, 1313611, 1313645, 1314989, 1314991,
1314994, 1315002, 1315042, 1315058, 1315113, 1315140, 1315183,
1315211, 1315245, 1315292, 1315294, 1315313, 1315328, 1315365,
1315378, 1315383, 1315623, 1315624, 1315625, 1315626, 1315632,
1315633, 1315636, 1315639, 1315640, 1315644, 1315646, 1317128,
1317133, 1317134, 1317135, 1317144, 1317301, 1326969, 1326969,
1326969, 1326970, 1326972, 1326973, 1326974, 1326977, 1326982,
1326983, 1326998, 1326999, 1327006, 1327008, 1327011, 1327546,
1342794, 1342852, 1342874, 1342882, 1342888, 1342957, 1342980,
1343007, 1343019, 1343036, 1343045, 1343094, 1343108, 1343125,
1343136, 1343266, 1343273, 1343292, 1343314, 1363701, 1363712,
1363725, 1363742, 1363791, 1363827, 1363850, 1363974, 1363976,
1364006, 1364034, 1364049;
b) Model number XD-CS1200-55 (for US distribution) lot numbers: 782706,
782707, 782708, 782708, 782708, 782718, 782724, 986901, 986902,
986904, 986908, 986909, 986910, 986911, 986912, 986915, 986916,
986918, 986919, 986921, 986922, 986922, 986922, 986922, 986922,
986925, 986932, 986934, 1130582, 1156888, 1156888, 1156888,
1212539, 1212540, 1212543, 1215499, 1215500, 1215506, 1215511,
1215511, 1215511, 1215514, 1242336, 1328479, 1328597, 1336891,
1337003.
Model number for XR-CS1200-55 (OUS distribution) lot numbers: 782873,
782875, 782876, 782877, 782878, 782879, 987127, 987128, 987129,
987130, 987131, 987132, 1302736, 1327016, 1344586, 1344591, 1344595,
1344614, 1344624, 1344626, 1344627, 1344633, 1346625, 1346626,
1346651, 1346676, 1346677, 1346678, 1364066, 1364075, 1364081,
1364082, 1364090, 1364099, 1364118, 1364170, 1364179, 1364186,
1364200, 1364226, 1364255, 1364283
RECALLING FIRM/MANUFACTURER
Ev3, Inc, Plymouth, MN, by letter dated February 13, 2006. Firm initiated recall is ongoing.
REASON
Loss of Operating Vacuum during use. It has been determined that a small percentage of X-Sizer Thrombectomy Catheter Systems from specific lots may lose operating vacuum prematurely due to a system leak within the Control Module. This failure can lead to the inability to complete the procedure of thrombus removal and the necessity to remove the device prior to achieving a satisfactory result.
VOLUME OF PRODUCT IN COMMERCE
1,463 devices
DISTRIBUTION
Nationwide and Internationally
 

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS I

______________________________
PRODUCT
Selecture, VEH, Polyglycolic Acid; Violet and Undyed Braided Coated; Synthetic Absorbable Suture, Recall # V-074-6
CODE
Description Lot # Mfg. Date Exp. Date: SH1 4/0 VIO PGA 70CM SPAHJ310 M574420 2004-09 2008-09; SH1 4/0 VIO PGA 70CM SPAHJ310 M620420 2004-10 2008-10; SH1 4/0 VIO PGA 70CM SPAHJ310 M626800 2004-11 2008-11; SH1 4/0 VIO PGA 70CM SPAHJ310 M804090 2005-10 2009-10; SH1 3/0 VIO PGA 70CM SPAHJ311 M577900 2004-09 2008-09; SH1 3/0 VIO PGA 70CM SPAHJ311 M620600 2004-11 2008-11; SH1 3/0 VIO PGA 70CM SPAHJ311 M804100 2005-09 2009-09; SH 3/0 VIO PGA 70CM SPAHJ316 M570440 2004-08 2008-08; SH 3/0 VIO PGA 70CM SPAHJ316 M574430 2004-08 2008-08; SH 3/0 VIO PGA 70CM SPAHJ316 M620510 2004-10 2008-10; SH 3/0 VIO PGA 70CM SPAHJ316 M772940 2005-08 2009-08; SH 2/0 VIO PGA 70CM SPAHJ317 M570450 2004-08 2008-08; SH 2/0 VIO PGA 70CM SPAHJ317 M574440 2004-10 2008-10; SH 2/0 VIO PGA 70CM SPAHJ317 M630240 2004-11 2008-11; SH 2/0 VIO PGA 70CM SPAHJ317 M773260 2005-08 2009-08; CT3 3/0 VIO PGA 70CM SPAHJ327 M577920 2004-09 2008-09; CT3 3/0 VIO PGA 70CM SPAHJ327 M630250 2004-11 2008-11; CT3 3/0 VIO PGA 70CM SPAHJ327 M804110 2005-09 2009-09; CT2 3/0 VIO PGA 70CM SPAHJ332 M570400 2004-08 2008-08; CT2 3/0 VIO PGA 70CM SPAHJ332 M574450 2004-08 2008-08; CT2 3/0 VIO PGA 70CM SPAHJ332 M620520 2004-10 2008-10; CT2 3/0 VIO PGA 70CM SPAHJ332 M749870 2005-05 2009-05; CT2 3/0 VIO PGA 70CM SPAHJ332 M768000 2005-06 2009-06; CT2 2/0 VIO PGA 70CM SPAHJ333 M577760 2004-10 2008-10; CT2 2/0 VIO PGA 70CM SPAHJ333 M620530 2004-10 2008-10; CT2 2/0 VIO PGA 70CM SPAHJ333 M626820 2004-11 2008-11; CT2 2/0 VIO PGA 70CM SPAHJ333 M767930 2005-06 2009-06; CT2 2/0 VIO PGA 70CM SPAHJ333 M772470 2005-07 2009-07; CT2 2/0 VIO PGA 70CM SPAHJ333 M772480 2005-08 2009-08; CT2 2/0 VIO PGA 70CM SPAHJ333 M777820 2005-07 2009-07; CT2 2/0 VIO PGA 70CM SPAHJ333 M795510 2005-08 2009-08; CT2 2/0 VIO PGA 70CM SPAHJ333 M808280 2005-10 2009-10; CT2 #0 VIO PGA 70CM SPAHJ334 M577950 2004-09 2008-09; CT2 #0 VIO PGA 70CM SPAHJ334 M620610 2004-10 2008-10; CT2 #0 VIO PGA 70CM SPAHJ334 M749880 2005-05 2009-05; CT1 2/0 VIO PGA 70CM SPAHJ339 M570380 2004-08 2008-08; CT1 2/0 VIO PGA 70CM SPAHJ339 M574640 2004-09 2008-09; CT1 2/0 VIO PGA 70CM SPAHJ339 M577770 2004-10 2008-10; CT1 2/0 VIO PGA 70CM SPAHJ339 M630260 2004-11 2008-11; CT1 2/0 VIO PGA 70CM SPAHJ339 M749890 2005-05 2009-05; CT1 2/0 VIO PGA 70CM SPAHJ339 M772490 2005-08 2009-08; CT1 2/0 VIO PGA 70CM SPAHJ339 M772500 2005-07 2009-07; CT1 2/0 VIO PGA 70CM SPAHJ339 M804120 2005-10 2009-10; CT1 #0 VIO PGA 70CM SPAHJ340 M570410 2004-08 2008-08; CT1 #0 VIO PGA 70CM SPAHJ340 M574180 2004-08 2008-08; CT1 #0 VIO PGA 70CM SPAHJ340 M630270 2004-11 2008-11; CT1 #0 VIO PGA 70CM SPAHJ340 M749900 2005-05 2009-05; CT1 #0 VIO PGA 70CM SPAHJ340 M772920 2005-07 2009-07; CT1 #0 VIO PGA 70CM SPAHJ340 M772930 2005-08 2009-08; CT1 #0 VIO PGA 70CM SPAHJ340 M819030 2005-10 2009-10; CT1 #1 VIO PGA 70CM SPAHJ341 M577980 2004-09 2008-09; CT1 #1 VIO PGA 70CM SPAHJ341 M620620 2004-10 2008-10; CT1 #1 VIO PGA 70CM SPAHJ341 M804150 2005-10 2009-10; CT1 #1 VIO PGA 70CM SPAHJ341 M819050 2005-10 2009-10; FS2 5/0 VIO PGA 70CM SPAHJ396 M577790 2004-08 2008-08; FS2 5/0 VIO PGA 70CM SPAHJ396 M620550 2004-11 2008-11; FS2 5/0 VIO PGA 70CM SPAHJ396 M804160 2005-10 2009-10; FS2 5/0 VIO PGA 70CM SPAHJ396 M845020 2005-11 2009-11; FS2 5/0 VIO PGA 70CM SPAHJ396 M845030 2005-11 2009-11; FS2 5/0 VIO PGA 70CM SPAHJ396 M845040 2005-11 2009-11; FS2 4/0 VIO PGA 70CM SPAHJ397 M570370 2004-08 2008-08; FS2 4/0 VIO PGA 70CM SPAHJ397 M574190 2004-08 2008-08; FS2 4/0 VIO PGA 70CM SPAHJ397 M574470 2004-08 2008-08; FS2 4/0 VIO PGA 70CM SPAHJ397 M630280 2004-11 2008-11; FS2 4/0 VIO PGA 70CM SPAHJ397 M749910 2005-05 2009-05; FS2 4/0 VIO PGA 70CM SPAHJ397 M767950 2005-06 2009-06; FS2 4/0 VIO PGA 70CM SPAHJ397 M772510 2005-07 2009-07; FS2 4/0 VIO PGA 70CM SPAHJ397 M772520 2005-08 2009-08; FS2 3/0 VIO PGA 70CM SPAHJ398 M570330 2004-08 2008-08; FS2 3/0 VIO PGA 70CM SPAHJ398 M574200 2004-08 2008-08; FS2 3/0 VIO PGA 70CM SPAHJ398 M574480 2004-09 2008-09; FS2 3/0 VIO PGA 70CM SPAHJ398 M749920 2005-05 2009-05; FS2 3/0 VIO PGA 70CM SPAHJ398 M767960 2005-06 2009-06; FS2 3/0 VIO PGA 70CM SPAHJ398 M772530 2005-08 2009-08; FS2 3/0 VIO PGA 70CM SPAHJ398 M772540 2005-07 2009-07; FS2 3/0 VIO PGA 70CM SPAHJ398 M804170 2005-10 2009-10; FS2 3/0 VIO PGA 70CM SPAHJ398 M819100 2005-10 2009-10; FS1 2/0 UNDYEPGA 70CM SPAHJ443 M632200 2005-03 2009-03; FS1 2/0 UNDYEPGA 70CM SPAHJ443 M749930 2005-05 2009-05; FS1 2/0 UNDYEPGA 70CM SPAHJ443 M767970 2005-06 2009-06; FS1 2/0 UNDYEPGA 70CM SPAHJ443 M772550 2005-07 2009-07; FS1 2/0 UNDYEPGA 70CM SPAHJ443 M781740 2005-08 2009-08; FS1 2/0 UNDYEPGA 70CM SPAHJ443 M808300 2005-09 2009-09; FS1 2/0 UNDYEPGA 70CM SPAHJ443 M808820 2005-10 2009-10; FS1 3/0 VIO PGA 70CM SPAHJ452 M570320 2004-08 2008-08; FS1 3/0 VIO PGA 70CM SPAHJ452 M620560 2004-10 2008-10; FS1 3/0 VIO PGA 70CM SPAHJ452 M620570 2004-10 2008-10; FS1 3/0 VIO PGA 70CM SPAHJ452 M626830 2004-11 2008-11; FS1 3/0 VIO PGA 70CM SPAHJ452 M626840 2004-11 2008-11; FS1 3/0 VIO PGA 70CM SPAHJ452 M630290 2004-12 2008-12; FS1 3/0 VIO PGA 70CM SPAHJ452 M719340 2005-06 2009-06; FS1 3/0 VIO PGA 70CM SPAHJ452 M749940 2005-05 2009-05; FS1 3/0 VIO PGA 70CM SPAHJ452 M767980 2005-06 2009-06; FS1 3/0 VIO PGA 70CM SPAHJ452 M772950 2005-08 2009-08; FS1 3/0 VIO PGA 70CM SPAHJ452 M772960 2005-07 2009-07; FS1 3/0 VIO PGA 70CM SPAHJ452 M808310 2005-09 2009-09; FS1 2/0 VIO PGA 70CM SPAHJ453 M606810 2004-10 2008-10; FS1 2/0 VIO PGA 70CM SPAHJ453 M606820 2004-10 2008-10; FS1 2/0 VIO PGA 70CM SPAHJ453 M606830 2004-10 2008-10; FS1 2/0 VIO PGA 70CM SPAHJ453 M620430 2004-10 2008-10; FS1 2/0 VIO PGA 70CM SPAHJ453 M626790 2004-11 2008-11; FS1 2/0 VIO PGA 70CM SPAHJ453 M719350 2005-06 2009-06; FS1 2/0 VIO PGA 70CM SPAHJ453 M749950 2005-05 2009-05; FS1 2/0 VIO PGA 70CM SPAHJ453 M768010 2005-06 2009-06; FS1 2/0 VIO PGA 70CM SPAHJ453 M772560 2005-07 2009-07; FS1 2/0 VIO PGA 70CM SPAHJ453 M772570 2005-08 2009-08; FS1 2/0 VIO PGA 70CM SPAHJ453 M811530 2005-09 2009-09; X1 2/0 VIO PGA 70CM SPAHJ461 M772580 2005-07 2009-07; X1 2/0 VIO PGA 70CM SPAHJ461 M779140 2005-07 2009-07; X1 2/0 VIO PGA 70CM SPAHJ461 M781800 2005-08 2009-08; CP1 2/0 VIO PGA 70CM SPAHJ466 M620650 2004-10 2008-10; CP1 2/0 VIO PGA 70CM SPAHJ466 M630300 2004-11 2008-11; CP1 2/0 VIO PGA 70CM SPAHJ466 M686890 2005-03 2009-03; CP1 2/0 VIO PGA 70CM SPAHJ466 M768020 2005-06 2009-06; CP1 2/0 VIO PGA 70CM SPAHJ466 M768030 2005-07 2009-07; CP1 2/0 VIO PGA 70CM SPAHJ466 M772590 2005-08 2009-08; CP1 2/0 VIO PGA 70CM SPAHJ466 M772600 2005-08 2009-08; CP1 2/0 VIO PGA 70CM SPAHJ466 M808320 2005-09 2009-09; CP1 2/0 VIO PGA 70CM SPAHJ466 M828860 2005-10 2009-10; CP1 #0 VIO PGA 70CM SPAHJ467 M574530 2004-08 2008-08; CP1 #0 VIO PGA 70CM SPAHJ467 M577740 2004-10 2008-10; CP1 #0 VIO PGA 70CM SPAHJ467 M630310 2004-11 2008-11; CP1 #0 VIO PGA 70CM SPAHJ467 M749960 2005-05 2009-05; CP1 #0 VIO PGA 70CM SPAHJ467 M772610 2005-08 2009-08; CP1 #0 VIO PGA 70CM SPAHJ467 M772620 2005-07 2009-07; CP1 #0 VIO PGA 70CM SPAHJ467 M777870 2005-07 2009-07; CP1 #0 VIO PGA 70CM SPAHJ467 M803540 2005-09 2009-09; CP1 #1 VIO PGA 70CM SPAHJ468 M577840 2004-09 2008-09; CP1 #1 VIO PGA 70CM SPAHJ468 M620590 2004-10 2008-10; CP1 #1 VIO PGA 70CM SPAHJ468 M630320 2004-12 2008-12; CP1 #1 VIO PGA 70CM SPAHJ468 M772970 2005-07 2009-07; CP1 #1 VIO PGA 70CM SPAHJ468 M811540 2005-09 2009-09; P1 6/0 UNDYEPGA 45CM SPAHJ489 M577850 2004-09 2008-09; P1 6/0 UNDYEPGA 45CM SPAHJ489 M768050 2005-06 2009-06; P1 6/0 UNDYEPGA 45CM SPAHJ489 M819110 2005-10 2009-10; FSL 2/0 VIO PGA 70CM SPAHJ586 M577860 2004-10 2008-10; FSL 2/0 VIO PGA 70CM SPAHJ586 M630330 2004-11 2008-11; FSL 2/0 VIO PGA 70CM SPAHJ586 M804180 2005-09 2009-09; FSL #0 VIO PGA 70CM SPAHJ587 M570390 2004-08 2008-08; FSL #0 VIO PGA 70CM SPAHJ587 M574540 2004-08 2008-08; FSL #0 VIO PGA 70CM SPAHJ587 M577750 2004-09 2008-09; FSL #0 VIO PGA 70CM SPAHJ587 M749970 2005-05 2009-05; FSL #0 VIO PGA 70CM SPAHJ587 M767810 2005-06 2009-06; FSL #0 VIO PGA 70CM SPAHJ587 M768060 2005-07 2009-07; FSL #0 VIO PGA 70CM SPAHJ587 M772400 2005-07 2009-07; FSL #0 VIO PGA 70CM SPAHJ587 M772410 2005-07 2009-07; FSL #0 VIO PGA 70CM SPAHJ587 M808330 2005-09 2009-09; FSL #0 VIO PGA 70CM SPAHJ587 M828870 2005-10 2009-10; CP #2 UNDYEPGA 70CM SPAHJ195 M632210 2005-04 2009-04; CP #2 UNDYEPGA 70CM SPAHJ195 M767870 2005-06 2009-06; CT3 2/0 VIO PGA 70CM SPAHJ328 M577940 2004-10 2008-10; CT1 3/0 VIO PGA 70CM SPAHJ338 M577970 2004-09 2008-09; CT1 3/0 VIO PGA 70CM SPAHJ338 M773460 2005-08 2009-08; CT1 3/0 VIO PGA 90CM SPAHJ344 M577990 2004-09 2008-09; CT1 2/0 VIO PGA 90CM SPAHJ345 M578000 2004-10 2008-10; CT1 2/0 VIO PGA 90CM SPAHJ345 M804230 2005-10 2009-10; CT1 2/0 VIO PGA 90CM SPAHJ345 M819060 2005-10 2009-10; CT1 #0 VIO PGA 90CM SPAHJ346 M578010 2004-09 2008-09; CT1 #0 VIO PGA 90CM SPAHJ346 M620630 2004-10 2008-10; C3 5/0 VIO PGA 45CM SPAHJ385 M573480 2004-08 2008-08; C3 5/0 VIO PGA 45CM SPAHJ385 M574460 2004-08 2008-08; FS2 3/0 VIO PGA 45CM SPAHJ393 M577780 2004-08 2008-08; FS2 3/0 VIO PGA 45CM SPAHJ393 M620540 2004-10 2008-10; FS2 3/0 VIO PGA 45CM SPAHJ393 M804250 2005-10 2009-10; SH 3/0 UNDYEPGA 70CM SPAHJ416 M577800 2004-10 2008-10; FS2 3/0 UNDYEPGA 70CM SPAHJ423 M573450 2004-08 2008-08; FS2 3/0 UNDYEPGA 70CM SPAHJ423 M804260 2005-10 2009-10; FS1 4/0 VIO PGA 70CM SPAHJ451 M577820 2004-10 2008-10; FS1 4/0 VIO PGA 70CM SPAHJ451 M804270 2005-10 2009-10; FS1 4/0 VIO PGA 70CM SPAHJ451 M819080 2005-10 2009-10; X1 3/0 VIO PGA 70CM SPAHJ460 M577830 2004-09 2008-09; X1 3/0 VIO PGA 70CM SPAHJ460 M773470 2005-08 2009-08; CP1 3/0 VIO PGA 70CM SPAHJ465 M620580 2004-10 2008-10; 2/0 VIO PGA 135CM SPAHJ615 M641650 2004-12 2008-12; #0 VIO PGA 135CM SPAHJ616 M641630 2004-12 2008-12; #0 VIO PGA 135CM SPAHJ616 M772360 2005-07 2009-07; #2 VIOPGA 135CM SPAHJ618 M641640 2005-03 2009-03; #2 VIOPGA 135CM SPAHJ618 M767890 2005-06 2009-06
RECALLING FIRM/MANUFACTURER
Recalling Firm: Schering Plough Animal Health Corporation, Summit, NJ, by letter on February 21, 2006.
Manufacturer: Surgical Specialties Corp., Reading, PA. Firm initiated recall is ongoing.
REASON
Efficacy issues with knot security and suture breakage leading to dehiscence.
VOLUME OF PRODUCT IN COMMERCE
314,965 sutures
DISTRIBUTION
Nationwide
 

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS II

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PRODUCT
Flunixin Meglumine Injection 50 mg/ml, each milliliter contains 50 mg. flunixin meglumine equivalent to flunixin, packaged in 250-mL bottles, ANDA 200-124, RX, Recall # V-077-6
CODE
Lot 5060735, Exp. 06/08
RECALLING FIRM/MANUFACTURER
IVX Animal Health Inc., Saint Joseph, MO, by telephone and letter on March 21, 2006, and by letter on May 24, 2006. Firm initiated recall is ongoing.
REASON
Low pH.
VOLUME OF PRODUCT IN COMMERCE
7,294 bottles
DISTRIBUTION
NE, NJ, CO, CA, TX, and WA

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PRODUCT
Merrick Five Star "WINGALING" dog food in 13.2 oz. metal cans, Recall # V-078-6
CODE
CAN CODES: 3M5WAL I 05347 ****H, 3M5WAL H 05353 ****H, 3M5WAL A 05362 ****H, 3M5WAL G 06003 ****H, 3M5WAL H 06003 ****H, 3M5WAL H 06004 ****H, 3M5WAL H 06006 ****H, 3M5WAL E 06012 ****H, 3M5WAL F 06012 ****H, 3M5WAL G 06017 ****H, 3M5WAL H 06017 ****H, 3M5WAL K 06024 ****H, 3M5WAL L 06025 ****H.
CASE CODES: I 05347, H 05353, A 05362, G 06003, H 06003, H 06006, H 06004, E 06012, F 06012, G 06017, H 06017, K 06024, L 06025
RECALLING FIRM/MANUFACTURER
Recalling Firm: Merrick Pet Care, Ltd., Amarillo, TX, by letter on April 24, 2006.
Manufacturer: Merrick Petfoods, Inc., Hereford, TX. Firm initiated recall is ongoing.
REASON
Pet food may contain metal tags.
VOLUME OF PRODUCT IN COMMERCE
192,667 cans
DISTRIBUTION
Nationwide and Internationally

END OF ENFORCEMENT REPORT FOR June 21, 2006

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