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U.S. Department of Health and Human Services

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Enforcement Report for May 20, 2009

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.

 

May 20, 2009
09-20

 

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS II

___________________________________
PRODUCT 
Pimento Cheese Spread packaged in 5 pound plastic tubs, 2 per case, under the following brands: St. Clair, Sysco Classic and Ron's Home Style Foods. Recall # F-234-9
CODE
5/1/2009
RECALLING FIRM/MANUFACTURER
St. Clair Food, Inc. Memphis, TN, by telephone and e-mails on January 12, 2009. Firm initiated recall is complete.
REASON
Product is manufactured under insanitary conditions, which can lead to micro-contamination.
VOLUME OF PRODUCT IN COMMERCE
4,040 lbs.
DISTRIBUTION
TN, TX, AR, KY

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS III

___________________________________
PRODUCT 
Harvest of Eden cut green beans, net wt. 6 lb. 6 oz, Product of China; UPC 1930351300. Recall # F-232-9
CODE
Case codes 08111011789M, 08111011789B, 0812132064C, 08110711786M, 08110711786D, 08110911788H and 0812142065P. The can code information is not available, but all cans imported into the U.S. are included in this recall.
RECALLING FIRM/MANUFACTURER
Recalling Firm: McFarling Foods, Inc. Indianapolis, IN, by email and telephone on March 20, 2009.
Manufacturer: Zhangzhou Tongfa Foods Industry, Co. Jiaomei Town, China. Firm initiated recall is complete.
REASON
There may be dead worms mixed in with the product.
VOLUME OF PRODUCT IN COMMERCE
269 cases
DISTRIBUTION
IN and KY
___________________________________
PRODUCT 
Cool River *** Bebidas Naturales *** Mezela de Frutas *** Two sizes: 16 oz. and 64 oz. Recall # F-233-9;
CODE
Lots # 810 Exp Date 12/15/2008, 811 Exp Date 12/15/2008 , 813 Exp Date 12/15/2008, 814 Exp Date 12/15/2008, 817 Exp Date 12/15/2008, 818 Exp Date 12/15/2008, 819 Exp Date 1/15/2009, 820 Exp Date 1/3/2009, 821 Exp Date 3/2/2009, 822 Exp date 3/6/2009, 823 Exp Date 3/7/2009 , 824 Exp Date 3/8/2009, 827 Exp Date 3/15/2009, 828 Exp Date 3/16/2009 , 829 Exp Date 3/19/2009 , 830 Exp Date 2/19/2009, 831 Exp Date 2/21/2009, 833 Exp Date 2/23/2009, 834 Exp Date 2/24/2009, 835 Exp Date 2/28/2009, 836 exp date 2/29/2009, 837 Exp Date 2/31/2009 , 839 Exp Date 3/5/2009, 842 Exp Date 3/10/2009, 843 Exp Date 3/11/2009, 844 Exp Date 3/13/2009, 846 Exp Date 3/17/2009, 847 Exp Date 3/18/2009, 848 Exp Date 3/19/2009, 851 Exp Date 3/24/2009, 854 Exp Date 4/2/2009, 855 Exp Date 4/3/2009, 856 Exp Date 4/5/2009, 857 Exp Date 4/8/2009, 859 Exp Date 4/11/2009 ,and 860 Exp Date 4/16/2009
RECALLING FIRM/MANUFACTURER
San Mar Manufacturing Corp. Catano, PR, by visit beginning on December 17, 2008. Firm initiated recall is complete.
REASON
Fruit Punch labeled as sugar-free actually contains corn fructose.
VOLUME OF PRODUCT IN COMMERCE
49,440 bottles
DISTRIBUTION
PR

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS II

___________________________________
PRODUCT 
a) Daytrana (methylphenidate transdermal system), 10 mg, 30 patches per box, Rx only, NDC 54092-552-30. Recall # D-410-2009;

b) Daytrana (methylphenidate transdermal system), 15 mg 30 patches per box, Rx only, NDC 54092-553-30. Recall # D-411-2009;

c) Daytrana (methylphenidate transdermal system), 20 mg 30 patches per box, Rx only, NDC 54092-554-30. Recall # D-412-2009;

d) Daytrana (methylphenidate transdermal system), 30 mg 30 patches per box, Rx only, NDC 54092-555-30. Recall # D-413-2009
CODE
a) Lot numbers: 2570611 (exp 04/30/2009), 2617011 (exp 06/30/2009), 2617111 (exp 07/31/2009), 2656911 (exp 08/31/2009) 3014511 (exp 05/31/2010), 2657212 (exp 08/31/2009), 3073511 (exp 05/31/2010), 2657211 (exp 08/31/2009), 2616311 (05/31/2009), 2617211 (06/30/2009);

b) Lot numbers: 2572011 (exp 05/31/2009), 2732811 (exp 09/30/2009), 27328111 (exp 09/30/2009);

c) Lot numbers: 2617811 (exp 06/30/2009), 2624711 (exp 06/30/2009), 2625211 (exp 7/31/2009), 3051911 (exp 05/31/2010), 31947 (exp 07/31/2010), 31949 (exp 07/31/2010), 31951 (07/31/2010), 33041 (exp 09/30/2010), 33042 (exp 09/30/2010), 34172 (exp 12/31/2010);

d) Lot numbers: 2572411 (exp 05/31/2009), 2572611 (exp 05/31/2009), 2573211 (exp 06/30/2009), 2573311 (exp 06/30/2009), 2573411 (exp 06/30/2009), 2652411 (exp 08/31/2009), 2733111 (exp 09/30/2009), 2737411 (exp 10/31/2009), 2750111 (exp 11/30/2009), 3015011 (exp 05/31/2010), 3015311 (exp 05/31/2010), 31739 (exp 06/30/2010), 31920 (exp 06/30/2010), 31921 (exp 06/30/2010), 31922 (exp 06/30/2010), 31923 (exp 06/30/2010), 2733211 (09/30/2009)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Shire PLC, Wayne, PA, by press release and letter on March 20, 2009.
Manufacturer: Noven Pharmaceuticals, Inc. Miami, FL. Firm initiated recall is ongoing.
REASON
Defective delivery system (mechanical [peel force out of specification).
VOLUME OF PRODUCT IN COMMERCE
245,204 boxes
DISTRIBUTION
CA, FL, IL, LA, MI, MN, MO, ND, NY, OH, PA, SC, and VT
___________________________________
PRODUCT 
Klonopin Wafers (clonazepam orally disintegrating wafers) CIV, 2 mg, carton of 60 blistered wafers (10 x 6), Rx only. NDC 0004-0283-22. Recall # D-414-2009
CODE
Lot number: U5011, Exp. Date 3/2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hoffmann La Roche, Inc. Nutley, NJ, by letters on March 26, 2009.
Manufacturer: Cardinal Health, Swindo, UK. Firm initiated recall is ongoing.
REASON
Subpotent
VOLUME OF PRODUCT IN COMMERCE
957 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
Sore Throat Lozenges, Pastillas para el dolor de la garganta, (Benzocaine 6mg and Menthol 10mg), 100 Lozenges. UPC Code 0 92265 08450 5. Recall # D-415-2009
CODE
Codes are for products manufactured from 3/3/2008 through 3/24/2009 as follows: C0038, C0198, D0088, E0058, F0248, I0084, K0198 and B02690511
RECALLING FIRM/MANUFACTURER
First Aid Only Inc. Vancouver, WA, by telephone and letter beginning on April 3, 2009. Firm initiated recall is ongoing
REASON
Misbranded; product labeled to contain Benzocaine and Menthol actually contains Hexylresorcinol.
VOLUME OF PRODUCT IN COMMERCE
726 boxes each containing 100 lozenges
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
a) Sterile Vancomycin Hydrochloride USP, Sterile Lyophilized Powder, Equivalent to 5 g Vancomycin, Pharmacy Bulk Package (100-ml vials)-Not for Direct Infusion, For Intravenous Use, NDC 0409-6509-01, Rx only. Recall # D-416-2009;

b) Sterile Vancomycin Hydrochloride, USP, For Intravenous Use, Sterile Powder packaged in a flip top vial, Equivalent to 1 g Vancomycin, Lyophilized, 10 units per immediate carton, 5 cartons per shipping case, Rx only, NDC 0409-6533-01. Recall # D-417-2009;

c) A-Hydrocort (Hydrocortisone Sodium Succinate) for Injection, USP, 100 mg, Sterile Powder for Injection packaged in a single-dose vial, Hydrocortisone Activity/2 mL (when mixed), Rx only, NDC 0409-4856-05, packaged in immediate cartons of 10 units, 10 cartons per shipping case. Recall # D-418-2009
CODE
a) Lot 72-030-DD, Exp. 1 Sep 2010, Lot 69-455-DD, Exp. 1 Jun 2010, and 70-170-DD, Exp. 1 Jul 2010;

b) Lot 65-060-DD, Exp. 1 May 2010, and Lot 64-006-DD, Exp. 1 Apr 2010;

c) Lot 59-560-DD, Exp. 1May 2009
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hospira Inc. Lake Forest, IL, by letters dated February 25, 2009 and e-mails on February 27, 2009.
Manufacturer: Hospira Inc. Mc Pherson, KS. Firm initiated recall is ongoing.
REASON
The sterility of the stoppers used on sterile products was potentially compromised.
VOLUME OF PRODUCT IN COMMERCE
a) 61,290 vials; b) 237,800 vials; c) 9,470 vials
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-0792-09
CODE
Unit: 0431920
RECALLING FIRM/MANUFACTURER
The Blood Center, New Orleans, LA, by telephone on January 23, 2008. Firm initiated recall is complete.
REASON
Blood product, which was out of controlled storage for an undocumented length of time, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT 
a) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-0877-09;
b) Platelets Pheresis Leukocytes Reduced. Recall # B-0878-09
CODE
a) Unit: W047009313501A;
b) Units: W047009313501B; W047009313501C
RECALLING FIRM/MANUFACTURER
New York Blood Center, Inc. Long Island City, NY, by telephone on January 9, 2009 and by letter on January 27, 2009. Firm initiated recall is complete.
REASON
Blood products, which did not meet acceptable product specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
NY
___________________________________
PRODUCT 
Platelets. Recall # B-0879-09
CODE
Unit: W0352082443636
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone and fax on January 13, 2009 and by letter on January 30, 2009. 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
TX
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced. Recall # B-0880-09
CODE
Unit: 9959396
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc. Orlando, FL, by telephone on December 23, 2008. Firm initiated recall is complete.
REASON
Blood product, which did not meet the acceptable product specifications for release, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced. Recall # B-0881-09
CODE
Unit: 72H989386
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc. Huntsville, AL, by fax on November 25, 2008. Firm initiated recall is complete.
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced. Recall # B-0882-09
CODE
Unit: 72J331851
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Lecanto, FL, by fax on January 6, 2009. Firm initiated recall is complete.
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT 
a) Fresh Frozen Plasma. Recall # B-0883-09;
b) Platelets. Recall # B-0884-09
CODE
a) and b) Unit: W035208258287D
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone and facsimile on January 26, 2009 and by letter on February 11, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received a piercing within 12 months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX
___________________________________
PRODUCT 
Red Blood Cells, Leukocytes Reduced, Recall # B-0886-09
CODE
W115908213390
RECALLING FIRM/MANUFACTURER
Central California Blood Center, Fresno, CA, by electronic mail on February 3 and February 4, 2009. 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
CA
___________________________________
PRODUCT 
Red Blood Cells, Recall # B-0888-09
CODE
Unit: W051508057163
RECALLING FIRM/MANUFACTURER
Recalling Firm: Memorial Blood Centers, Saint Paul, MN, by electronic mail on February 5, 2009 and by letter on February 10, 2009.
Manufacturer: Memorial Blood Centers – Duluth, Duluth, MN. 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
MN
___________________________________
PRODUCT 
Red Blood Cells, Recall # B-0890-09
CODE
Unit: 1465735
RECALLING FIRM/MANUFACTURER
Recalling Firm: Memorial Blood Centers, Saint Paul, MN, by electronic mail on February 6, 2009 and by letter on February 10, 2009.
Manufacturer: Memorial Blood Centers – Duluth, Duluth, MN. 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
MN
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-0894-09
CODE
Units: Y86695, W087608511525
RECALLING FIRM/MANUFACTURER
Virginia Blood Service, Inc. Richmond, VA, by letter dated August 7, 2008 and one dated August 21, 2008. Firm initiated recall is complete.
REASON
Blood products, labeled “leukoreduced”, but which had not undergone leukoreduction, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
VA
___________________________________
PRODUCT 
Platelets Pooled Leukocytes Reduced, Recall # B-0896-09
CODE
Unit: 72Z233659
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc. Gainesville, FL, by facsimile on January 8, 2009. Firm initiated recall is complete.
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-0897-09
CODE
Unit: W035208226069D
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone and facsimile on January 9, 2009 and by electronic mail on February 23, 2009 and April 1, 2009. 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
TX
___________________________________
PRODUCT 
a) Red Blood Cells Leukocytes Reduced, Recall # B-0899-09;
b) Recovered Plasma, Recall # B-0900-09
CODE
a) and b) Unit: W045007142739
RECALLING FIRM/MANUFACTURER
Community Blood Center of Greater Kansas City, Kansas City, MO, by facsimile and letter dated February 24, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who resided with a person diagnosed with Hepatitis B, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Austria and KS
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-0901-09
CODE
Unit: 72J399845
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc. Huntsville, AL, by facsimile on January 28, 2009. Firm initiated recall is complete.
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT 
Source Plasma, Recall # B-0902-09
CODE
Units: BG0466747; BG0466987
RECALLING FIRM/MANUFACTURER
Bowling Green Biologicals LLC, Bowling Green, KY, by facsimile on January 12, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received a tattoo within 12 months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NC, CA
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-0904-09
CODE
Unit: W041508026895U
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc – Lubbock Center, Lubbock, TX, by letter dated February 6, 2009.
Manufacturer: Blood Systems, Inc. San Angelo, TX. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to a malaria endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT 
a) Platelets Pheresis Leukocytes Reduced, Recall # B-0905-09;
b) Platelets Pheresis Leukocytes Reduced Irradiated, Recall # B-0906-09
CODE
a) Units: 9936850 Part 1 and Part 2;
b) Unit: 9936850 Part 3
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc. Orlando, FL, by telephone on November 11, 2008. Firm initiated recall is complete.
REASON
Blood products, with a low platelet count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
FL
___________________________________
PRODUCT 
a) Platelets, Recall # B-0907-09;
b) Red Blood Cells, Recall # B-0908-09
CODE
a) Units: 1687665; 1680091; 1668635;
b) Units: 1687665; 1680091; 1668635; 1659354
RECALLING FIRM/MANUFACTURER
Blood Bank of Hawaii, Honolulu, Hawaii, by letter on January 20, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who warranted deferral due to travel to a malaria endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
Hawaii
___________________________________
PRODUCT 
a) Red Blood Cells, Recall # B-0909-09;
b) Platelets, Recall # B-0910-09
CODE
a) Units: 1686172; 1676364; 1666345;
b) Units: 1676364; 1666345
RECALLING FIRM/MANUFACTURER
Blood Bank of Hawaii, Honolulu, Hawaii, by letter dated January 6, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled to a malaria endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
Hawaii
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-0911-09
CODE
Unit: 6684522 Part 1 and Part 2
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc. Orlando, FL, by telephone on December 14, 2008. Firm initiated recall is complete.
REASON
Blood products, which did not meet acceptable product specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-0915-09
CODE
Units: W035808149103 (2 units)
RECALLING FIRM/MANUFACTURER
BloodSource, Inc. Mather, CA, by telephone and facsimile on December 8, 2008. Firm initiated recall is complete.
REASON
Blood products, with low platelet count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-0916-09
CODE
Unit: 02GG49085
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Wichita, KS, by telephone and electronic notification on December 31, 2008 and by facsimile on January 6, 2009. 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
TX
___________________________________
PRODUCT 
Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-0918-09
CODE
Units: W035808134835, W035808149455
RECALLING FIRM/MANUFACTURER
BloodSource, Inc. Mather, CA, by telephone and facsimile on January 29, 2009 and February 3, 2009. Firm initiated recall is complete.
REASON
Blood products, for which the quality control testing for volume was not performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-0919-09
CODE
Unit: 004FS17175
RECALLING FIRM/MANUFACTURER
ARC Blood Services, New England Region, Dedham, MA, by facsimile on January 14, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
ME
___________________________________
PRODUCT 
Red Blood Cells, Recall # B-0920-09
CODE
Unit: 6927596
RECALLING FIRM/MANUFACTURER
Community Blood Center of the Ozarks, Springfield, MO, by letter dated February 9, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MO
___________________________________
PRODUCT 
Red Blood Cells, Recall # B-0921-09
CODE
Unit: 6927594
RECALLING FIRM/MANUFACTURER
Community Blood Center of the Ozarks, Springfield, MO, by letter dated February 9, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MO
___________________________________
PRODUCT 
Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-0935-09
CODE
Unit: W087608821647
RECALLING FIRM/MANUFACTURER
Virginia Blood Service, Inc. Richmond, VA, by letter dated September 16, 2008. Firm initiated recall is complete.
REASON
Blood product, collected with an absolute RBC volume above the acceptable range, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
VA
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-0936-09
CODE
Units: W091009114761 Part 1 and Part 2
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute – Sylvan N Goldman Center, Oklahoma City, OK, by telephone on January 7, 2009 and by fax on January 19, 2009. Firm initiated recall is complete.
REASON
Blood product, which did not meet acceptable product specification, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX, OK
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-0937-09
CODE
Unit: W071208019749
RECALLING FIRM/MANUFACTURER
Medic Inc. Knoxville, TN, by letter on January 21, 2009. 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
TN
___________________________________
PRODUCT 
a) Red Blood Cells, Recall # B-0938-09;
b) Platelets Pooled Leukocytes Reduced, Recall # B-0939-09
CODE
a) Unit: 6749518;
b) Unit: 1011393
RECALLING FIRM/MANUFACTURER
LifeShare Community Blood Services, Elyria, OH, by letter on February 5, 2009. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OH
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced Irradiated, Recall # B-0940-09
CODE
Unit: W038308015271
RECALLING FIRM/MANUFACTURER
Mississippi Valley Region Building Center, Davenport, IA, by telephone and fax on December 15, 2008. 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
IA

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

___________________________________
PRODUCT 
Source Plasma, Recall # B-0691-09
CODE
Unit: JB0099257
RECALLING FIRM/MANUFACTURER
DCI Biologicals Jonesboro, LLC, Jonesboro, AK, by e-mail and telephone on August 11, 2005. Firm initiated recall is complete.
REASON
Blood product, which was untested for human immunodeficiency virus (HIV) and hepatitis C virus (HCV) by the nucleic acid test (NAT) method, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-0864-09
CODE
Unit: 35GY34842
RECALLING FIRM/MANUFACTURER
American National Red Cross, Roanoke, VA, by telephone on March 31, 2006. Firm initiated recall is complete.
REASON
Blood product, in which QC for the centrifuge was not performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MD

___________________________________
PRODUCT 
Recovered Plasma, Recall # B-0885-09
CODE
W115908213390
RECALLING FIRM/MANUFACTURER
Central California Blood Center, Fresno, CA, by electronic mail on February 3 and February 4, 2009. 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
Austria
___________________________________
PRODUCT 
Recovered Plasma, Recall # B-0887-09
CODE
Unit: W051508057163
RECALLING FIRM/MANUFACTURER
Recalling Firm: Memorial Blood Centers, Saint Paul, MN, by electronic mail on February 5, 2009 and by letter on February 10, 2009.
Manufacturer: Memorial Blood Centers – Duluth, Duluth, MN. 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
Switzerland
___________________________________
PRODUCT 
Recovered Plasma, Recall # B-0889-09
CODE
Unit: 1465735
RECALLING FIRM/MANUFACTURER
Recalling Firm: Memorial Blood Centers, Saint Paul, MN, by electronic mail on February 6, 2009 and by letter on February 10, 2009.
Manufacturer: Memorial Blood Centers – Duluth, Duluth, MN. 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
Switzerland
__________________________________
PRODUCT 
a) Red Blood Cells Leukocytes Reduced, Recall # B-0891-09;
b) Fresh Frozen Plasma, Recall # B-0892-09;
c) Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-0893-09
CODE
a) W226908930020, W226908930023, W226908930021, W226908930015, W226908930018, W226908930001, W226908930002, W226908930009, W226908930010, W226908930011;

b) W226908930014, W226908930016, W226908930018;

c) W226908930008 (Part 1 and Part 2)
RECALLING FIRM/MANUFACTURER
Virginia Blood Services RMH Blood Center, Harrisonburg, VA, by letter dated July 14, 2008. Firm initiated recall is complete.
REASON
Blood products, labeled with an extended expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE
15 units
DISTRIBUTION
VA
___________________________________
PRODUCT 
Red Blood Cells, Recall # B-0895-09
CODE
Unit: 6914858
RECALLING FIRM/MANUFACTURER
Community Blood Center of the Ozarks, Springfield, MO, by letter dated February 12, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor with a history of receiving an allograft, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AK
___________________________________
PRODUCT 
Recovered Plasma, Recall # B-0898-09
CODE
Unit: W035208226069D
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone and facsimile on January 9, 2009 and by electronic mail on February 23, 2009 and April 1, 2009. 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
Austria
___________________________________
PRODUCT 
Recovered Plasma, Recall # B-0917-09
CODE
Unit: 02GG49085
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Wichita, KS, by telephone and electronic notification on December 31, 2008 and by facsimile on January 6, 2009. 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
CA

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS I

___________________________________
PRODUCT 
SmartMonitor 2 Infant Apnea Monitor. The monitor is intended for use in the continuous monitoring of respiration and heart rate of infant patients in a home or hospital environment. The monitor detects and alarms for periods of central apnea and high or low heart rates. Model Number 4002 and Model Number 4003. Recall # Z-1411-2009.
CODE
Serial Numbers 3000033364 through 3000038740 and Serial Numbers 3000033364 through 3000038740
RECALLING FIRM/MANUFACTURER
Respironics, Inc. Murrysville, PA, by letter dated April 23, 2009. Firm initiated recall is ongoing.
REASON
Audible alarm failure.
VOLUME OF PRODUCT IN COMMERCE
4,791 units
DISTRIBUTION
Nationwide and Canada

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

****CORRECTION****
Enforcement Report for May 13, 2009, Ethicon, Inc. Recall #’s Z-1310-2009 through Z-1316-2009. The following changes were made to the above recall in the Code Information:
1) Lot # APM668, APZ284 , APZ627, APZ895, APZ096, APZ076, APM085, APM270, APM271, AP2312, AP2423, AP2462, APZ117, APM842, APZ756, APZ116, APZ244, AP2566, AP2597, APZ460, AP2634, AP2519, APZ291, APZ778, APZ782, AP2589, APM525, APM400, APM482, AP6072, APZ014, APM324, APM938, APZ276, APM031, APM214, APZ402, AP2093, APZ961, APZ410, APZ856, AP6080, APZ472, APM382, APZ167, APZ337, APZ932, APZ459, APZ766, APZ767, AP6077, AP2539, AP2615, AP2407, and APZ195.

2) Lot # AP2507, AP2695, AP2599, AP2501, APM984, APZ416, APZ191, APZ804, APM982, APZ289, APZ031, AP6025, AP6083, APM591, APZ372, and APZ254.

3) Lot # APZ334, APM964, APM965, APZ063, APZ155, APZ156, and APZ476;

5) Lot # Expiration Date APM091 2013-07-31 12:00AM APM861 2013-07-31 12:00AM APZ105 2013-07-31 12:00AM AMK590 2013-07-31 12:00AM APZ721 2013-07-31 12:00AM APZ098 2013-07-31 12:00AM APZ283 2013-07-31 12:00AM APM692 2013-07-31 12:00AM APM753 2013-07-31 12:00AM AP6005 2013-07-31 12:00AM APM748 2013-07-31 12:00AM APZ367 2013-07-31 12:00AM APM298 2013-07-31 12:00AM APZ245 2013-07-31 12:00AM AP6053 APZ644 2013-07-31 12:00AM APM524 2013-07-31 12:00AM APZ908 2013-07-31 12:00AM AP6061 2013-07-31 12:00AM APM635 2013-07-31 12:00AM APZ126 2013-07-31 12:00AM APZ298 2013-07-31 12:00AM APZ153 2013-07-31 12:00AM APZ381 2013-07-31 12:00AM AP2315 2013-07-31 12:00AM AP2333 2013-07-31 12:00AM AP2331 2013-07-31 12:00AM AP2332 2013-07-31 12:00AM AP2241 2013-07-31 12:00AM AP2355 2013-07-31 12:00AM APM221 2013-07-31 12:00AM APM844 2013-07-31 12:00AM;

6) Lot number Expiration Date APM639 2010-07-31 12:00AM APM937 2010-07-31 12:00AM APZ507 2010-07-31 12:00AM APM952 2010-07-31 12:00AM APM660 2010-07-31 12:00AM APM651 2010-07-31 12:00AM APM726 2010-07-31 12:00AM APM599 2010-07-31 12:00AM; 
The lots numbers for Products 4, 7, & 8 stayed the same. 
___________________________________
PRODUCT 
Roche MagNA Pure LC Workstation. Robotic workstation for automated isolation of nucleic acids from different kinds of crude sample material such as whole blood, serum, blood cells, culture cells, tissue, bacteria and fungi. Recall # Z-1255-2009
CODE
Product Numbers: 12236931001, 12236931444, 12236931692 and 03670325001.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Roche Diagnostics Corp. Indianapolis IN, by letter dated February 9, 2009. 
Manufacturer: Roche Instrument Center AG, Rotkreuz, Switzerland. Firm initiated recall is ongoing.
REASON
Protruding screw threads may cut the user when cleaning the interior of the instrument.
VOLUME OF PRODUCT IN COMMERCE
371 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Zimmer Sirus Intramedullary nail for tibia, cannulated, diameter 12 L, 330 mm, sterile, Zimmer GmbH, Winterthur, Switzerland; REF 02.02631.233. The device is used in orthopedic trauma surgeries for stabilization of tibial bone fractures. Recall # Z-1261-2009
CODE
Lot Number: 2385866
RECALLING FIRM/MANUFACTURER
Recalling Firm: Zimmer Inc. Warsaw, IN, by telephone on March 23, 2009 and letter dated March 31, 2009.  
Manufacturer: Zimmer GMBH, Winterthur, Switzerland. Firm initiated recall is ongoing.
REASON
The package is labeled as containing 330 mm length nails, but actually contains 300 mm length nails.
VOLUME OF PRODUCT IN COMMERCE
32 units
DISTRIBUTION
FL, MO, NJ, NY, OH, OK, TX and countries of Austria, Japan, Korea and Germany
___________________________________
PRODUCT 
Carina Home Ventilator. The device is used as a continuous respirator/ventilator for home use. Catalog Numbers 5704757 and 5704758. Recall # Z-1263-2009
CODE
Software version 1.1 - 2.4
RECALLING FIRM/MANUFACTURER
Draeger Medical, Inc. Telford, PA, by letters dated January 2009 and January 22, 2009.
Manufacturer: Drager HomeCare, Best, Netherlands. Firm initiated recall is ongoing.
REASON
The device may not generate a pilot line disconnect alarm if the pilot line becomes disconnected, which may potentially result in a substantial reduction in tidal volume delivery.
VOLUME OF PRODUCT IN COMMERCE
40 units
DISTRIBUTION
CA, FL, GA, HI, IL, LA, MA, MN, OH, and TX
___________________________________
PRODUCT
Smiths Medical BCI(R) Advisor(R) Vital Signs Monitor, model 9200, catalog numbers: 920654225, 920674225, 920674235, 925454220, 925454235, 925454320, 925454325, 925454330, 925454335, 925457325, 925474325, 925654225, 925654325, 925754325, 925754335, and 92M774325. Intended to be used in the ICU, CCU, OR, ER, RR, Labor and Delivery rooms, special procedure labs and other areas of a hospital or clinic where low-end monitoring systems are needed. Recall # Z-1326-2009
CODE
Serial numbers: AM08070014, AM08070015, AM08080004, AM08080005, AM08080006, AM08080007, AM08080008, AM08080009, AM08080010, AM08080011, AM08080012, AM08080013, AM08080014, AM08080015, AM08080016, AM08080017, AM08080018, AM08080019, AM08080032, AM08080033, AM08080034, AM08080035, AM08080036, AM08080037, AM08080038, AM08080039, AM08080040, AM08080041, AM08080042, AM08080043, AM08080044, AM08080045, AM08080046, AM08080047, AM08080048, AM08080049, AM08080050, AM08080051, AM08080052, AM08080075, AM08080076, AM08080077, AM08080078, AM08080079, AM08090058, AM08090059, AM08090060, AM08090061, AM08090069, AM08090070, AM08090071, AM08090072, AM08090073, AM08090074, AM08090075, AM08090076, AM08090077, AM08090078, AM08090079, AM08090080, AM08090081, AM08090082, AM08090083, AM08090084, AM08090085, AM08090086, AM08090092, AM08090093, AM08090094, AM08090095, AM08090096, AM08090097, AM08100000, AM08100001, AM08100002, AM08100003, AM08100004, AM08100005, AM08100006, AM08100007, AM08100008, AM08100042, AM08100043, AM08100045, AM08100051, AM08100052, AM08100053, AM08100054, AM08100056, AM08100075, AM08100076, AM08100077, AM08100078, AM08100080, AM08100082, AM08100083, AM08100085, AM08100086, AM08100087, AM08100088, AM08100089, AM08100091, AM08100092, AM08100093, AM08100094, AM08100095, AM08100096, AM08100097, AM08100098, AM08100099, AM08100100, AM08100101, AM08100146, AM08110000, AM08110001, AM08110003, AM08110004, AM08110005, AM08110008, AM08110009, AM08110010, AM08110011, AM08110012, AM08110013, AM08110014, AM08110015, AM08110016, AM08110018, AM08110019, AM08110026, AM08110027, AM08110028, AM08110029, AM08110030, AM08110031, AM08110034, AM08110035, AM08110036, AM08110037, AM08110054, AM08110055, AM08110056, and AM08110058
RECALLING FIRM/MANUFACTURER
Smiths Medical PM, Inc. Waukesha, WI, by letters dated December 22, 2008 and January 16, 2009. Firm initiated recall is ongoing.
REASON
Recent improvements were made to the Advisor case plastic resulting in the inserts being deeply embedded into the plastic. This affects the ability of the monitor to be adequately secured on the wall mount bracket or roll stand bracket, resulting in the monitor falling off. There have been no adverse events or injuries reported.
VOLUME OF PRODUCT IN COMMERCE
143 units
DISTRIBUTION
FL, GA, NJ, NY, and TN and countries of Argentina, Brazil, Ecuador, Greece, Peru, Romania, Russia, Singapore, Slovenia, Trinidad and Tobago, United Kingdom, and Uruguay
___________________________________
PRODUCT 
Centricity TriWin Laboratory Information System; The Centricity TriWin Laboratory product is a laboratory information system. It is designed to facilitate the general clinical, anatomic pathology, and cytology laboratory workflow such as order entry, results entry, instrument interfacing, results reporting and patient record retrieval. Recall # Z-1397-2009
CODE
Software version 7.3
RECALLING FIRM/MANUFACTURER
Recalling Firm: GE Healthcare Integrated IT Solutions, Barrington, IL, by letter dated November 17, 2008.
Manufacturer: Triple G Systems Group, Inc. Markham, Canada. Firm initiated recall is ongoing.
REASON
A software defect in the Centricity Lab (TriWin) product may incorrectly link patient information to a wrong report. Also, when viewing results in Patient Viewer, and a coagulation result is higher or lower than the linearity limit, then all of the results following the higher or lower result will show the same result as the first flagged result.
VOLUME OF PRODUCT IN COMMERCE
26 units
DISTRIBUTION
Nationwide and Canada

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III

___________________________________
PRODUCT
Diagnostics Chemical Limited Iron Assay Catalog Number: 102-25 For the In Vitro quantitative determination of iron in serum. Recall # Z-1327-2009
CODE
Lot Number: 33361, Exp: October 2010
RECALLING FIRM/MANUFACTURER
Diagnostic Chemicals, Ltd. Charlottetown Prince Edward Island, Canada, by letter on March 14, 2008. Firm initiated recall is complete.
REASON
Precipitate in product may cause elevated background absorbance interference.
VOLUME OF PRODUCT IN COMMERCE
153 kits
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  VETERINARY - CLASS II

___________________________________
PRODUCT 
Dry Roasted Peanuts Animal Feed Grade packaged in 2,000 lb. totes and 50 lb. poly-lined paper bags. 2,000 lb. totes labeled as: Control# WT-60802 and WT-14484, Contents Dry Roast Peanuts, Not for Human Consumption. 50 lb poly-lined paper bags labeled as: Premium Dry Roast Peanuts, For Wildlife Feeding Only (Not for Human Consumption). Product of the USA. Recall # V-160-2009
CODE
2000 lb totes identified with Control# WT-60802 and WT-14484. No Product codes applied to the 50 lb bags.
RECALLING FIRM/MANUFACTURER
Western Trade Group, Inc. Port Angeles, WA, by telephone and fax between February 5, 2009 and February 9, 2009 and by press release on February 11, 2009. Firm initiated recall is ongoing.
REASON
The product was manufactured using peanut products recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
84,453 lbs.
DISTRIBUTION
IA, KY and ND
___________________________________
PRODUCT 
Healthy Hide Deli-Wraps Flavor Filled 3 Pack 5" Wraps Peanut Butter Flavor. Made in Colombia. UPC 0 91093 33354 0. Recall # V-161-2009
CODE
A 08 208, A 08 212, A 08 232, A 08 234, A 08 263, A 08 264, A 08 268, A 08 275, A 08 276, and A 08 277
RECALLING FIRM/MANUFACTURER
Recalling Firm: Salix Corp. Deerfield Beach, FL, by e-mail on January 23, 2008.
Manufacturer: PEPCO LTDA, Bogota, Colombia. Firm initiated recall is ongoing.
REASON
The product was manufactured using peanut butter recalled by Peanut Corporation of America because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
911 cases (60 packs per case)
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT 
Bark Bars in a variety of sizes and flavors as listed below. Creamy Peanut Butter UPC 725999522004; PB & Carob Chips UPC 725999523001; Lucious Carob UPC 725999521007; 4pack Cookiebar Assortment UPC 725999538005; Peanut Butter Crunch: 12 oz UPC 725999001103; 16 oz UPC 725999161104; Bark Bars Peanut Butter: 1.5oz Jumbo UPC 725999000168; 2.25 Pillow Pack UPC 725999333105; 2.5lb canister UPC 725999005064; 5 lb bulk UPC 725999001257; 6 oz Smiles UPC 725999530009; Giggles UPC 725999530009; Christmas Stocking 6 oz UPC 725999000175; Christmas Card Mailer UPC 725999513003; Birthday Mailer UPC 725999528006; "With Love" Hearts UPC 725999512944; Holiday Smiles UPC 725999222300; 100 Calorie 2 oz Pillow Pack UPC 725999539101; 100 Calorie 14 oz dispenser UPC 725999539200; Gravity Trial 2 oz UPC 725999400166; Bark Bars Minis UPC 72599953300; Bark Bars Animal Snackers 3 oz UPC 725999512098; 12 oz UPC 725999512098; Bark Bars Milk & Cookies UPC 725999333808; Dog Ate My Homework Jumbo UPC 725999531006; 2 oz Pillow Pack UPC 725999535004; Bark Bars Naughty or Nice UPC 725999530092; Bark Bars Carob & Peanut Butter: 2.5lb canister UPC 725999005071; 2.25oz Pillow Pack UPC 725999333402; 5 lb bulk UPC 725999003251; Bark Bars Brownie Delight 12 oz UPC 725999003107; 5 lb bulk UPC 725999003251. Recall # V-162-2009
CODE
Best by dates of 3/2008 through 8/2009 and 10/2009 through 12/2009.
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Health Kennels, Inc. Pompano Beach, FL, by press release on February 13, 2009. Firm initiated recall is ongoing.
REASON
The products were manufactured using peanut butter recalled by Peanut Corporation of America because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION

Nationwide and Canada
___________________________________
PRODUCT 
a) Grreat Choice Dog Biscuits, Small Assorted 32 oz., UPC 73725702900. Recall # V-163-2009;

b) Grreat Choice Dog Biscuits, Small/Medium Assorted 4 lb., SKU 1411289, UPC 73725700601. Recall # V-164-2009;

c) Grreat Choice Dog Biscuits, Small/Medium Assorted 8 lb., SKU 1411288, UPC 73725700605. Recall # V-165-2009;

d) Grreat Choice Dog Biscuits, Small/Medium Assorted 10 lb., SKU 5102523, UPC 73725702755. Recall # V-166-2009;

e) Grreat Choice Dog Biscuits, Large Assorted 8 lb., SKU 1411399, UPC 73725700638.
Recall # V-167-2009;

f) Grreat Choice Dog Biscuits, Extra Large Assorted 8 lb., SKU 1411988, UPC 73725700779. Recall # V-168-2009;

g) Grreat Choice Dog Biscuits, Peanut Butter 4 lb., SKU 1411986, UPC 73725700766. Recall # V-169-2009
CODE
Sold between Aug. 21, 2008 and Jan. 19, 2009
RECALLING FIRM/MANUFACTURER
Recalling Firm: Petsmart, Inc. Phoenix, AZ, by an internal “Fetch Message” on January 19, 2009.
Manufacturer: American Nutrition Inc. Ogden, UT. Firm initiated recall is ongoing.
REASON
The product was manufactured using peanut butter recalled by Peanut Corporation of America because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
264,441 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT 
a) Peanut butter filled rawhide chew bones in 4 inch and 6 inch sizes sold under the Carolina Prime Pet brand name. The product is packed in clear plastic bags with a cardboard label. The catalog item numbers for 4" is 42003, UPC 63725542003; and for 6" is 42005, UPC 63725542005. The products are labeled in part "*** CAROLINA PRIME Peanut Butter STUFFED 6" (OR 4") RAWHIDE BONE ***".  Recall # V-170-2009;

b) Peanut butter filled beef hooves sold 2 hooves per package under the Carolina Prime Pet brand name. The product is packaged in clear plastic bags with a cardboard label. The catalog item number is 42000, UPC 63725542000. The product is labeled in part, "*** CAROLINA PRIME Peanut Butter STUFFED Natural Hooves 2 BEEF HOOVES ***".
Recall # V-171-2009;  

c) Peanut butter filled 6 inch beef shank bones sold under the Carolina Prime Pet brand name and Salix Healthy-Hide brand name. The product is packaged in clear plastic bags with a cardboard label. The catalog item number for the Carolina Prime brand is 42007, UPC 6372554200; and for Healthy Hide brand is 33479, UPC 09109333479. The Carolina Prime product is labeled in part, "***CAROLINA PRIME Peanut Butter STUFFED Natural Smoked Bone 6" Meaty BEEF SHANK ***". The Healthy-Hide product is labeled in part,"*** PEANUT BUTTER FILLED Salix Healthy-Hide REAL BONE DOG TREATS * Peanut Butter Filled BEEF SHANK BONE ***". Recall # V-172-2009;
CODE
All date codes between 081508 and 010909
RECALLING FIRM/MANUFACTURER
Recalling Firm: Carolina Prime Pet, Murphy, NC, by letter on January 27, 2009.
Manufacturer: Peanut Corporation of America, Blakely, GA. Firm initiated recall is ongoing.
REASON
The product was manufactured using peanut butter recalled by Peanut Corporation of America because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
Hooves-approx 28,400 packages; 4" rawhide-approx 24,510 packages; 6" rawhide-approx 37,968; Carolina Shank-approx 37,280 packages; Salix Shank-approx 35,232 packages
DISTRIBUTION
AZ, FL, GA, IL, NV, NC, OH
___________________________________
PRODUCT 
a) Product label reads in part: "SAFEGARD HOG DEWORMER MEDICATED For Growing Swine. For the removal of: Lungworms***Gastrointestinal worms***large roundworm***ACTIVE DRUG INGREDIENT Fenbendazole...22.65mg/lb**** 57107***Bulk or 50 lbs (22.68 kg) Net Weight". Recall # V-173-2009; 

b) Product label reads in part: "SAFEGUARD BEEF DEWORMER MINERAL MEDICATED FOR THE REMOVAL AND CONTROL OF: LUNGWORMS***STOMACH WORMS***INTESTINAL WORMS***ACTIVE DRUG INGREDIENT Fenbendazole....3800g/ton***INGREDIENTS Processed Grain Byproducts*** Bulk or 50lb (22.68kg) Net Weight***". Recall # V-174-2009 
CODE
a) The recalled codes are stamped on the ingredient label and are as follows: 3433.880220088 M139810, 3433.88031108 M160550, 3433.88032808 M174580, 3433.88052308 M233550, 3433.88062008 M246880, 3433.88071808 M275520, 3433.88072508 M283530, and 3433.88011309 M473200. Example of Breakdown of the code is: 3433.88022008 M139810 3433. - Commodity code, hog dewormer 88 - Plant location code, Hermiston, OR 022008 - manufacturing date, February 20, 2008 M139810 - mix report and lot number;

b) The recalled codes are stamped on the ingredient label and are as follows: 2577.88032408 M174519 Breakdown of the code is: 2577.88032408 M174519 2577. - Commodity code, beef dewormer mineral 88 - Plant location code, Hermiston, OR 032408- manufacturing date, March 24, 2008 M174519 - mix report and lot number
RECALLING FIRM/MANUFACTURER
CHS Nutrition, Hermiston, OR, by telephone on February 17, 2009. Firm initiated recall is ongoing.
REASON
The firm manufactured medicated beef dewormer using a drug (Fenbendazole) that was expired.
VOLUME OF PRODUCT IN COMMERCE
809 - 50 lb bags of hog dewormer; 20 - 50 lb bags of beef dewormer
DISTRIBUTION
WA, OR, ID
___________________________________
PRODUCT 
a) Lidocaine Hydrochloride Injectable 2%, packaged in 100- and 250-ml. bottles, RX, under the following brand names and labels: (1) Aspen Veterinary Resources Ltd. Lidocaine HCl Injectable 2%, (100-ml. only); (2) Phoenix Pharmaceutical, Inc. Lidocaine Hydrochloride Injectable-2%; (3) VEDCO Lidocaine Hydrochloride Injectable-2%; (4) Butler Lidoject Lidocaine 2% Injectable; (5) Pro Labs Ltd. Lidocaine HCl Injectable-2%, (100-ml. only); and (6) AmTech Group, Inc. Lidocaine HCl Injectable-2%, Recall # V-175-2009;

b) Thiamine Hydrochloride Injection 200 mg/ml, packaged in 100- and 250-ml. bottles, RX, under the following private labels and product names: (1) Phoenix Pharmaceutical, Inc. Thiamine Hydrochloride Injection; (2) VEDCO Thiamine Hydrochloride Injection; (3) AmTech Group Inc. Thiamine Hydrochloride Injection, (both 100- and 250-ml.); and (4) VetTek Thiamine Hydrochloride Sterile Solution. Recall # V-176-2009;

c) Vitamin C Injectable Solution, packaged in 100-ml. and 250-ml. bottles, RX, under the following labels: (1) Phoenix; (2) VetTek, (250-ml. only); (3) VEDCO; and (4) AmTech Group Inc. Recall # V-177-2009;

d) OvaCyst (Gonadorelin Diacetate Tetrahydrate), 50 mcg/mL, Sterile Solution, packaged in 12- and 36-ml. multi-dose glass vials, RX, ANDA 200-069. The product is manufactured under a number of labels as follows: (1) VEDCO; (2) AgriLabs; (3) RXV; (4) Butler; (5) Phoenix; (6) Aspen; (7) Phoenix Scientific Animal Health, (36-ml. only); and (8) VetTek. Recall # V-178-2009;

e) Epinephrine Injection packaged in 30-ml. multi-dose vials, RX, under the following brand names and labels: (1) VEDCO Epinephrine Injection 1:1000; (2) VetTek Epinephrine Injection USP 1:1000; (3) Butler Epinject (Epinephrine Injection USP) 1:1000; (4) Phoenix Pharmaceutical Inc. Epinephrine Injection USP 1:1000; (5) AmTech Group, Inc. Epinephrine Injection USP 1:1000; and (6) RXV Products Epinephrine Injection, USP 1:1000. Recall # V-179-2009;

f) Sterile Water for Injection, USP, Nonpyrogenic, packaged in 100- and 250-ml. vials, RX, under the following labels: (1) Phoenix Pharmaceutical, Inc., (100-ml); (2) VEDCO, (100-ml); (3) AgriLabs, (250-ml.); and (4) Butler, (100- and 250-ml). Recall # V-180-2009 Sterile Water for Injection, USP, Nonpyrogenic, packaged in 100- and 250-ml. vials, RX, under the following labels: (1) Phoenix Pharmaceutical, Inc., (100-ml); (2) VEDCO, (100-ml); (3) AgriLabs, (250-ml.); and (4) Butler, (100- and 250-ml). Recall # V-180-2009
CODE
a) 100-ml. bottles - Lots 6030381, Exp. 3/09; 6040552, Exp. 4/09; 6050804, Exp. 5/09; 6071063, Exp. 7/09; 6081210, Exp. 8/09; 6091537, Exp. 9/09; 6101670, Exp. 10/09; 6101772, Exp. 11/09; 7010038, Exp. 1/10; 7020265, Exp. 2/10; 7030360, Exp. 3/10; 7040544, Exp. 4/10; 7050694, Exp. 5/10, 7050695, Exp. 5/10; 7060943, Exp. 6/10; and 8100681, Exp. 10/11; 250-ml. bottles - Lots 6040627, Exp. 4/09; 6071155, Exp. 7/09; 6091545, Exp. 9/09; 6111906, Exp. 11/09; 7020232, Exp. 2/10; 7030468, Exp. 3/10; 7040546, Exp. 4/10; 7060826, Exp. 6/10; 7081086, Exp. 8/10; 8100738, Exp. 10/11; and 8100748, Exp. 10/11;

b) 100-ml. bottles - Lots 6030338, Exp. 3/09; 7050818, Exp. 5/10; and 8120852, Exp. 12/11; 250-ml. bottles - Lot 7060828, Exp. 6/10;

c) 100-ml. bottles - Lots 6101713, Exp. 10/09; 7020266, Exp. 02/10; 7060832, Exp. 6/10; 8100724, Exp. 10/11; and 250-ml. bottles- Lots 6050815, Exp. 5/09; 6071182, Exp. 7/09; 6101719, Exp. 10/09; 6122001, Exp. 12/09; 7030362, Exp. 3/10; 7060827, Exp. 6/10; and 8100713, Exp. 10/11;

d) Lots 7030370, 7030371, 7030372, 7030488, and 7030492, exp. date 3/09; Lots 7040554, 7040555, 7040635, and 7040644, exp. date 4/09; 7050707, 7050708, 7050709, and 7050710, exp. date 5/09; Lots 7060838, 7060839, and 7060840, exp. date 6/09; Lots 7070966 and 7070967, exp. date 7/09; and Lots 7081092, 7081093, and 7081094, exp. date 8/09;

e) Lots 7060857, Exp. 2/10; 8100753, Exp. 10/11; and 8100764, Exp. 11/11;

f) 100-ml - Lot 8100727, Exp. 10/11; 250-ml - Lot 809123F, Exp. 9/11
RECALLING FIRM/MANUFACTURER
TEVA Animal Health Inc. Saint Joseph, MO, by telephone and letters between March 9, 2009 and April 17, 2009 and by letters on April 27, 2009. Firm initiated recall is ongoing.
REASON
The products have the potential to contain particulate matter.
VOLUME OF PRODUCT IN COMMERCE
542,577/100-ml, 139,776/250-ml, 192,989/36-ml, 128,525/12-ml, and 51,271/30-ml
DISTRIBUTION
Nationwide

END OF ENFORCEMENT REPORT FOR MAY 20, 2009

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