FDA

Enforcement Report

April 23, 2003
03-17

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I

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PRODUCT
Enfamil EnfaCare LIPIL powdered infant formula. Recall # F-330-3.
CODE
Lot BMR01. Exp. 1 JAN 04.
RECALLING FIRM/MANUFACTURER
Bristol Myers Squibb Company, Evansville, IN, by press release, letter, and telephone beginning on January 9, 2003. FDA initiated recall is complete.
REASON
Enterobacter sakazakii contamination.
VOLUME OF PRODUCT IN COMMERCE
505 cases.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II

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PRODUCT
Glycopyrrolate USP, G136, bulk powder, drum, Rx only, Caution: For Manufacturing, Processing, or Repacking. Recall # D-196-3.
CODE
Lot# 021438.
RECALLING FIRM/MANUFACTURER
Boehringer Ingelheim Chemicals, Inc, Petersburg, VA, by letter on October 25, 2002. Firm initiated recall is complete.
REASON
Contamination; bulk drug contains glass.
VOLUME OF PRODUCT IN COMMERCE
28.7 kg.
DISTRIBUTION
GA and Canada.

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PRODUCT
Zyvox oral suspension (linezolid for oral suspension), 100 mg/5 ml, 150 ml (when constituted), Rx only. Recall # D-214-3.
CODE
Lots 11HKU, 97HAH, 82HHW, 16HXK, 61JBC, 94JAM, 08HDC, 10HHM, 22HFC, 63HJD, 64HJD, 11HMC, 12HMC, 34HMC, 75HKU, 86HMJ, 14JAH, 15JAH, 18HXP, 19HXP, 21HXP, 22HXP, 31JAK, 53JAY, 59JBC, 76HXP, 77HXK, 91HYT,and 96HWY.
RECALLING FIRM/MANUFACTURER
Pharmacia Corporation, Kalamazoo, MI, by letters dated March 18, 2003. Firm initiated recall is ongoing.
REASON
Superpotent.
VOLUME OF PRODUCT IN COMMERCE
21,127 units.
DISTRIBUTION
Nationwide and Austria, Australia, Barbados, Belgium, China, Equador, Germany, Greece, Hong Kong, India, Ireland, New Zealand, Qatar, Russia, Singapore, South Africa, Spain, Sri Lanka, Switzerland, and the United Kingdom
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PRODUCT
GEMZAR (Gemcitabine HCl For Injection),1 g equivalent to base, For I.V. use only, Sterile, Single Use Vial, Rx only , VIAL No. 7502. Recall # D-216-3.
CODE
Lot# 5NG55M.
RECALLING FIRM/MANUFACTURER
Lilly, Eli & Co., Indianapolis, IN, by letters issued on March 20, 2003. FDA initiated recall is ongoing.
REASON
Lack of assurance of sterility (cracked vials).
VOLUME OF PRODUCT IN COMMERCE
112,210.
DISTRIBUTION
Nationwide.
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PRODUCT
Norfloxacin USP, bulk powder, 25 g bottles, For Prescription Compounding, Caution: For Manufacturing, Processing or Repacking, Federal law prohibits dispensing without prescription. Recall # D-218-3.
CODE
Lot 980611-3, Exp. 06/2003.
RECALLING FIRM/MANUFACTURER
Medisca Pharmaceutique, Inc., Saint-Laurent, Canada, via telephone on March 5, 2003, and letters dated March 6, 2003. Firm initiated recall is ongoing.
REASON
Mislabeled; bottle labeled to contain Norfloxacin USP actually contains Grepafloxacin USP.
VOLUME OF PRODUCT IN COMMERCE
2 - 25 gm units.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

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PRODUCT
a) Platelets. Recall # B-0750-3;
b) Platelets, Irradiated. Recall # B-0751-3;
c) Fresh Frozen Plasma. Recall # B-0752-3.
CODE
a) Unit numbers G02226, L23641, R15276, R15277, R15278,
R15279, R15280, R15282, V42570, and V44411;
b) Unit numbers G02225, G02228, T12226, T12227, and V42571;
c) Unit numbers P68212, P68213, P70563, T12225, T12226,
and T12227.
RECALLING FIRM/MANUFACTURER
Tacoma-Pierce County Blood Bank, Cascade Regional Blood Services, Tacoma, WA, by letter on April 23, 2002. Firm initiated recall is complete.
REASON
Blood products, prepared more than eight hours after collection of the corresponding units of Whole Blood, were distributed.
VOLUME OF PRODUCT IN COMMERCE
a) 10 units;
b) 5 units;
c) 6 units.
DISTRIBUTION
WA, WI, and SC.

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PRODUCT
Source Plasma. Recall # B-0756-3.
CODE
Unit number DZDSJP.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., Eugene, OR, by facsimile on May 22, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose arm inspection was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IL.

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PRODUCT
Source Plasma. Recall # B-0757-3.
CODE
Unit number 71862835.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., Salem, OR, by facsimile on April 3, 2002. Firm initiated recall is complete.
REASON
Blood product, that tested negative for human immunodeficiency virus (HIV) p24 antigen, but was collected from a donor that subsequently tested repeatedly reactive for HIV p24 antigen, was not properly quarantined and was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.

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PRODUCT
Source Plasma. Recall # B-0758-3.
CODE
Unit numbers 46405975, 46408389, 47151369, 47155527, 46989093, 46985385, 47205734, 47208797, 57403298, 57406237, 57342504, 57346779, 57757483, 57759104, 59418740, 59222613, 59227588, 59187264, 59359463, and 59111467.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., Salem, OR, by facsimile on November 20, 2001, and February 4, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor that was not tested for syphilis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
20 units.
DISTRIBUTION
CA.

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PRODUCT
Red Blood Cells, Irradiated. Recall # B-0768-3.
CODE
Unit number 0551094.
RECALLING FIRM/MANUFACTURER
Nalani 2 Outpatient Oncology, Honolulu, HI, by telephone and letter on December 22, 2001. Firm initiated recall is complete.
REASON
Blood product, labeled with the incorrect expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
HI.

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PRODUCT
Source Plasma. Recall # B-0771-3.
CODE
Unit number G-12679-030.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Alpha Therapeutic Corporation, Los Angeles, CA, by facsimile on February 13, 2003.
Manufacturer: Alpha Therapeutic Corporation, Youngstown, OH. Firm initiated recall is complete.
REASON
Blood products, collected from a donor that did not answer the medical history questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Spain.

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PRODUCT
a) Hepatitis B Virus Core Antigen (Recombinant) Diagnostic
Kit, Corzyme. Recall # B-0772-3;
b) Antibody to Hepatitis B Surface Antigen (Mouse
Monoclonal) Diagnostic Kit, Auszyme_ Monoclonal.
Recall # B-0773-3;
c) Hepatitis C Virus Encoded Antigen (Recombinant c100-3,
HC-31, and HC-34) Diagnostic Kit, Abbott HCV EIA 2.0.
Recall # B-0774-3.
CODE
a) Lot number 92847M300;
b) Lot numbers 92549M302, 93157M302, 92549M300,
92549M301, and 93157M300;
c) Lot number 93786M200.
RECALLING FIRM/MANUFACTURER
Abbott Laboratories HPD/ADD, Abbott Park, IL, by telephone on November 27, 2002 and by letters on December 31, 2002. Firm initiated recall is complete.
REASON
Hepatitis B and C test kits contained conjugate or conjugate diluent vials that could leak.
VOLUME OF PRODUCT IN COMMERCE
a) 1 lot;
b) 5 lots;
c) 1 lot.
DISTRIBUTION
Nationwide, and Thailand and Singapore.

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PRODUCT
Red Blood Cells Leukocytes Removed. Recall # B-0775-3.
CODE
Unit 12GY47495.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Carolinas Region, Charlotte, NC, by telephone on March 1, 2002. Firm initiated recall is complete.
REASON
Blood product, which tested positive for anti-E antibodies but was labeled as negative for unexpected antibodies, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NC.

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PRODUCT
a) Gammazyme-F_ (Stable Ficin Solution).
Recall # B-0776-3;
b) Ficin Solution. Recall # B-0777-3.
CODE
a) Lot EF50-1;
b) Lot ENZ137 (component of Ficin Panel One System Package,
lots 0122802, 0205814, 0219853, 0305866, 0319903,
0402916, 0416954, 0430966, and 0514004; and Ficin Panel
Two System Package, lots 0212827, 0312878, 0409928, and
0507979).
RECALLING FIRM/MANUFACTURER
Gamma Biologicals, Inc, Houston, TX, by letter and facsimile on July 11, 2002, and July 17, 2002. Firm initiated recall is complete.
REASON
Ficin reagent, which exhibited a loss in potency during post-release testing, was distributed.
VOLUME OF PRODUCT IN COMMERCE
a) 923 vials;
b) 3241 vials.
DISTRIBUTION
Nationwide and Internationally.

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PRODUCT
Source Plasma (For Manufacturing Use). Recall # B-0779-3.
CODE
Unit number 71909844.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., Lakewood, WA, by facsimile dated March 12, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose arm inspection was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.

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PRODUCT
Misys Laboratory_ Blood Bank System computer software (3 versions). Recall # B-0791-3.
CODE
Version numbers 5.2, 5.23, and 5.3.
RECALLING FIRM/MANUFACTURER
Misys Healthcare Systems, Tucson, AZ, by facsimile on January 10, 2003. Firm initiated recall is Complete.
REASON
Blood bank computer software contained a defect that could result in the incomplete displaying of red blood cell antigen and antibody information for a unit of blood.
VOLUME OF PRODUCT IN COMMERCE
3 versions.
DISTRIBUTION
Nationwide, United Kingdom, Ireland, Canada, Bermuda, and Saudi Arabia.

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PRODUCT
a) Red Blood Cells. Recall # B-0793-3;
b) Platelets. Recall # B-794-3.
CODE
a) and b) Unit number FT97394.
RECALLING FIRM/MANUFACTURER
Inova Health Care Services, Blood Donor Services, Annandale, VA, by letter on June 10, 2002. Firm initiated recall is complete.
REASON
Blood products, that tested initially reactive for human immunodeficiency virus (HIV) p24 antigen, was not appropriately retested in duplicate and was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MD, and Washington D.C.

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III

***CORRECTION***

The Enforcement Report of April 9, 2003 for Class III, Recall # Z-0668-03 stated Toshiba American Med Systems, Inc. recalled by letters of February 12 & February 13, 2002. The letters were issued on February 12 & February 13, 2003.

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE - CLASS II
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PRODUCT
Unlabeled bulk "Cattle Feed" sold by weight to user/farmers who pick it up at the firm. Product is a ruminant feed used to feed beef cattle. Recall # V-046-3.
CODE
Product is bulk and uncoded.
RECALLING FIRM/MANUFACTURER
Zephyr Feed Company, Zephyrhills, FL., by letters on March 19, 2003 and March 26, 2003. FDA initiated recall is ongoing.
REASON
Cattle feed was distributed to farmers that may contain prohibited protein for ruminants.
VOLUME OF PRODUCT IN COMMERCE
517,990 lbs.
DISTRIBUTION
FL.

END OF ENFORCEMENT REPORT FOR APRIL 23, 2003

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