Enforcement Report

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.

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November 17, 2004
04-46

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I

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PRODUCT
Amy's brand Enchilada with Black Bean and Vegetable, Made with Organic Tortillas, Non Dairy; The product comes in 10 ounce retail package frozen with UPC 42272 00051. Recall # F-072-5.
CODE
Lot number F174C embossed on side panel, where F corresponds to the month 17 corresponds to the day manufactured, 4 is the year, and C is the shift. In this case, product was produced June 17, 2004 in the third shift.
RECALLING FIRM/MANUFACTURER
Amy's Kitchen, Inc., Santa Rosa, CA, by press release on October 5, 2004 and October 15, 2004. Firm initiated recall is ongoing.
REASON
Some packages labeled as Bean and Vegetable Enchiladas, Non Dairy, actually contain Cheese Enchiladas.
VOLUME OF PRODUCT IN COMMERCE
400 cases.
DISTRIBUTION
AL, AR, MN, IL, MO, and KS.

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PRODUCT
The Club Sandwich, Ready-to-Eat refrigerated "The Club" Sandwich in white triangle/wedge shape packed with a transparent poly film seal. Net Wt. 5.15 ox (146g). Dandee brand/logo. Recall # F-073-5.
CODE
Sell by Sep 03.
RECALLING FIRM/MANUFACTURER
Dandee Food Company, Jacksonville, FL, by Press Release, telephone and letters on August 27, 2004. Firm initiated recall is ongoing.
REASON
Club sandwiches are contaminated with Listeria Monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
4,195 Sandwiches.
DISTRIBUTION
FL and GA.

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PRODUCT
a) American Spoon brand Cherry-Berry Nut Mix in 6 oz. and 1 pound packages.
Recall # F-074-5;
b) American Spoon brand Bar Mix, an all natural mix with sesame sticks, in 7 oz. packages.
Recall # F-075-5.
CODE
All packages with a best if used by date of on or before August 18, 2004.
RECALLING FIRM/MANUFACTURER
American Spoon Foods, Inc., Petoskey, MI, by Press Release and letters on June 2, 2004. Firm initiated recall is complete.
REASON
The product was manufactured using almonds recalled by Paramount Farms due to their association with an outbreak of Salmonella Enteritidis infection.
VOLUME OF PRODUCT IN COMMERCE
2,100 pounds.
DISTRIBUTION
MA and MI.

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II

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PRODUCT
Ciprofloxacin Ophthalmic Solution USP 0.3%, Each ml contains
3.5mg ciprofloxacin hydrochloride equivalent to ciprofloxacin
base 3 mg, 10 mL plastic dropper bottles, Sterile, Rx only,
For Topical Opthalmic Use Only, NDC 24208-444-10.
Recall # D-059-5.
CODE
Lot numbers: 775221, 775222, 775231, 775232, 765661, 785181, 785182, 785791, 785792, 805591 and 805602.
RECALLING FIRM/MANUFACTURER
Bausch & Lomb, Inc., Tampa, FL, by letters on October 19, 2004. Firm initiated recall is ongoing.
REASON
Presence of Particulate Matter (stability).
VOLUME OF PRODUCT IN COMMERCE
142,459 bottles.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III

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PRODUCT
Amnesteem (Isotretinoin), 40 mg capsules, packaged in 3 x 10 count blister packs within cardboard display box, Rx only, NDC 62794-614-93. Recall # D-054-5.
CODE
Lot # RP044731P, Exp Nov 2004.
RECALLING FIRM/MANUFACTURER
Bertek Pharm, Greenboro, NC, by letter on October 8, 2004. Firm initiated recall is ongoing.
REASON
Dissolution Failure.
VOLUME OF PRODUCT IN COMMERCE
19,280 boxes.
DISTRIBUTION
Nationwide.

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PRODUCT
a) Lotrimin AF Antifungal (Clotrimazole cream 1%), 12 gram
tubes. Recall # D-055-5;
b) Lotrimin AF Antifungal Jock Itch, (Clotrimazole cream 1%),
12g tubes. Recall # D-056-5;
c) Clotrimazole Cream, USP, 1%, 15g and 30g tubes, Rx only.
Recall # D-057-5.
CODE
a) Lot Number 2-KPE-402, NDC Number 11523-0963-7,
Expiration Date: 02-05;
b) Lot Number 2-KPE-102, NDC Number 11523-1125-1,
Expiration Date: 03-05;
c) Lot Number 2-KPE-203, NDC Number 59930-1570-1,
Expiration Date: 01-05;
Lot Number 2-KPE-401, NDC Number 59930-1570-2,
Expiration Date: 01-05.
RECALLING FIRM/MANUFACTURER
Schering Plough Corp., Kenilworth, NJ, by letter on August 19, 2004. Firm initiated recall is ongoing.
REASON
Impurities/Degradation Products.
VOLUME OF PRODUCT IN COMMERCE
463,356 tubes.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

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PRODUCT
Ortho Assay Protocol Diskette (OAPD) for the Vironostika® HTLV-I/II Microelisa system; Revision 1 (For Use with the Ortho Summit™ Sample Handling System). Recall # B-0132-5.
CODE
Serial # 6901871-001 thru --065 version 1.0, OAPD.
RECALLING FIRM/MANUFACTURER
Ortho Clinical Diagnostics, Raritan, NJ, by letters dated December 1, 2003 and May 27, 2004. Firm initiated recall is complete.
REASON
Defects in the design of instrument software where inconsistent liquid levels occur while pipetting Human T-Lymphotropic Viruses Type I and Type II (HTLV-I/II) microwell plates.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Nationwide.

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PRODUCT
a) Red Blood Cells. Recall # B-0154-5;
c) Red Blood Cells, Leukocytes Reduced. Recall # B-0155-5;
d) Recovered Plasma. Recall # B-0156-5.
CODE
a) Units 20FJ02869, 20FH04132;
b) Unit 20FH05645;
c) Units 20FJ02869, 20FH04132, 20FH05645.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Lewis and Clark Region, Boise, ID, by facsimile on August 1, 2001 or by letter dated August 3, 2001. Firm initiated recall is complete.
REASON
Blood products, which tested negative for hepatitis, but were collected from an ineligible donor due to a history of jaundice, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units.
DISTRIBUTION
CA and Switzerland.

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PRODUCT
a) Amplicor [3] AV-HRP Avidin-HRP (Horseradish Peroxidase) BGG Conjugate;
b) Amplicor [3] AV-HRP Avidin-HRP (Horseradish Peroxidase) BGG Conjugate.
Recall # B-0178-5.
CODE
a) Lot No. E09569, found in kit Lot No. E11360, Material No. 21118560018,
expiration January, 2005;
b) Lot No. E09569, found in kit Lot No. E11231, Material No. 21117750123,
expiration September, 2004 (This lot was only distributed to foreign consignees).
RECALLING FIRM/MANUFACTURER
Roche Molecular Systems, Inc., Belleville, NJ, by e-mail dated June 24, 2004 and a Revised Important Product Advice Notice was sent on July 6, 2004. Firm initiated recall is complete.
REASON
AMPLICOR HIV-1 MONITOR Test Kits, with an increased frequency of "blue foci" that potentially can cause elevated A450 background in microwell plate wells during PCR detection, were distributed.
VOLUME OF PRODUCT IN COMMERCE
a) 8,400 kits;
b) 1,256 kits.
DISTRIBUTION
IN, Japan and Germany.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

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PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0100-5.
CODE
Unit number: KE72385.
RECALLING FIRM/MANUFACTURER
Sacramento Medical Foundation, Sacramento, CA, by letter, dated July 12, 2002. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 Unit.
DISTRIBUTION
NY.

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PRODUCT
Recovered Plasma. Recall # B-0114-5.
CODE
Unit 2408046..
RECALLING FIRM/MANUFACTURER
South Texas Blood & Tissue Center, San Antonio, TX, by facsimile dated February 4, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from a donor with a history of taking anti-seizure medication, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Switzerland.

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PRODUCT
Red Blood Cells. Recall # B-0149-5.
CODE
Unit 2093926.
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center, Inc., Lexington, KY, by letter dated August 26, 2004. Firm initiated recall is complete.
REASON
Red Blood Cells, that may have contained clots, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
OH.

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

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PRODUCT
a) Oral-B CrossAction Power Toothbrush, Soft (Battery Operated) Handle Colors:
Blue, Pink, Green and Purple NDC 0-69055-82662-1. Recall # Z-0180-05;
b) Oral-B CrossAction Power Toothbrush, Medium (Battery Operated) Handle Colors:
Blue, Pink, Green and Purple NDC 0-69055-82445-0. Recall # Z-0181-05;
c) Oral-B CrossAction PowerMAX Rechargeable Toothbrush, Soft 4 Accent Colors:
Blue, Pink, Green and Purple NDC 0-69055-83293-6. Recall # Z-0182-05;
d) Oral-B CrossAction PowerMAX Rechargeable Toothbrush, Medium NDC 0-69055-83120-5.
Recall # Z-0183-05;
e) Oral-B CrossAction Power Brushhead Refills, Soft 2-Count Pack NDC 0-69055-82663-8.
Recall # Z-0184-05;
f) Oral-B CrossAction Power Brushhead Refills, Medium 2-Count Pack NDC 0-69055-82448-1.
Recall # Z-0185-05.
CODE
All.
RECALLING FIRM/MANUFACTURER
Gillette Research Institute, Needham, MA, by letters on October 27, 2004. Firm initiated recall is ongoing.
REASON
Brushhead may unlatch from the power handle.
VOLUME OF PRODUCT IN COMMERCE
22,304 million.
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III

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PRODUCT
The Enfant Evoked Response Photic Stimulator. The Enfant A Pediatric Vision Testing Device. Each medical device unit is assembled and contains an 18 inch flat panel vision stimulator panel, a 17 inch flat panel operator monitor, a 2.25 inch thermal printer, a mobile point of care cart, medical grade battery back-up, speaker, a CPU with floppy and CD drives, a camera and an isolation transformer. Recall # Z-0186-05.
CODE
No manufacturing codes are affixed to the units. The firm maintains some in-house identification numbers which are: 10001; 10003; 10004; 10005; 10006; 10007; 10008; 10009; 100010; 100011; 100012; 100013; 100014; 100015; 100016.
RECALLING FIRM/MANUFACTURER
Diopsys Inc., Metuchen, NJ, by letter on September 14, 2004. Firm initiated recall is ongoing.
REASON
The firm has not established a medical device quality system, a quality plan, nor quality procedures.
VOLUME OF PRODUCT IN COMMERCE
18 units.
DISTRIBUTION
NY, NJ, and CT.

END OF ENFORCEMENT REPORT FOR November 17, 2004

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