FDA

Enforcement Report

January 26, 2000                                           00-04

RECALLS AND FIELD CORRECTIONS:  FOODS -- CLASS I
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PRODUCT
Stella D'oro Lady Stella Assortment Cookies/Biscuits, net weight 
400 g (15 ounces).  Recall #F-085-0.
CODE
All coded of UPC 73510 00255 on the market at the time of the 
recall.
MANUFACTURER
Stella D'oro Biscuit Company, Inc., Bronx, New York.
RECALLED BY
Manufacturer, by telephone, and by issuing an allergy alert on 
November 19, 1999, followed by fax.  Firm-initiated recall 
ongoing.
DISTRIBUTION
Canada.
QUANTITY
50 cases were distributed.
REASON
Product contains undeclared hazelnuts, cashews, and almonds.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
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PRODUCT
Land O'Lakes Orange Juice Plus Calcium From Concentrate, in half-
gallon (1.89L) containers.  Recall #F-086-0.
CODE
Oct 31 M followed by 1854E through 1940E.
MANUFACTURER
Foremost Farms, Madison, Wisconsin.
RECALLED BY
Land O'Lakes, Inc., Arden Hills, Minnesota, by visit on or about 
October 1, 1998.  Firm-initiated recall complete.
DISTRIBUTION
Minnesota, North Dakota, Wisconsin.
QUANTITY
Firm estimates none remains on the market.
REASON
Product contained undeclared pineapple juice.
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PRODUCT
Grower's Pride Fruit Punch, in 16 fluid ounce glass containers.  
Recall #F-087-0.
CODE
Date Code: EHCER.
MANUFACTURER
Citrus World, Inc., Lake Wales, Florida.
RECALLED BY
Manufacturer, by letter on April 13, 1999.  Firm-initiated recall 
complete.
DISTRIBUTION
Florida, Michigan, North Carolina, Wisconsin, California, 
Virginia, Ohio, Texas, Maryland, Pennsylvania, Minnesota.
QUANTITY
1,084 cases (12 bottles per case) were distributed.
REASON
Product contains undeclared pineapple juice, water-extracted 
orange solids, grapefruit juice, artificial flavors, and FD&C Red 
No. 40.

RECALLS AND FIELD CORRECTIONS:  FOODS -- CLASS III
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PRODUCT
Mega Min Dietary Supplement, in 100-tablet bottles, OTC dietary 
supplement.  Recall #F-088-0.
CODE
Lot 019-3061.
MANUFACTURER
Vitalabs, Inc., Jonesboro, Georgia.
RECALLED BY
Manufacturer, by letter August 30, 1999.  Firm-initiated recall 
complete.
DISTRIBUTION
Southeastern United States.
QUANTITY
2-3 cases (48-72 bottles) were distributed.
REASON
Some bottles labeled as "Mega Min" actually contain a different 
supplement, namely, "Formula 7".

RECALLS AND FIELD CORRECTIONS:  DRUGS -- CLASS II
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UPDATE
Recall #D-187-0 (Perrigo Co., Allegan, Michigan), Acetaminophen 
Tablets, 500 mg, Product Code 405, packaged in bottles of 100, 
under various brand names, which appeared in the January 5, 2000 
Enforcement Report should read:
REASON:  Tablet discoloration due to mold 
(penicillium species).

RECALLS AND FIELD CORRECTIONS:  DRUGS -- CLASS III
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PRODUCT
Quinidine Gluconate Extended Release Tablets, USP, 324 mg, in 
100-tablet bottles, Rx for conversion of atrial 
fibrillation/flutter; reduction of frequency of relapse into 
atrial fibrillation/flutter; and suppression of ventricular 
arrhythmias.  NDC #53489-141-01.  Recall #D-207-0.
CODE
Lot #39239 EXP 8/01.
MANUFACTURER
Mutual Pharmaceutical Company, Philadelphia, Pennsylvania.
RECALLED BY
Manufacturer, by letter dated January 10, 2000.  Firm-initiated 
recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
5,836 bottles were manufactured.
REASON
Dissolution failure (12 month stability 8 hours time point).

RECALLS AND FIELD CORRECTIONS:  DEVICES -- CLASS II
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PRODUCT
Toshiba Powervision 6000 Diagnostic Ultrasound Device.
Recall #Z-321-0.
CODE
Model Number SSA-37OA. Only those units which have the optional 
equipment of the wheel casters (Part #UZCK-370A) are being 
recalled.
MANUFACTURER
Toshiba Corporation, Otawara-Shi, Tochigi-Ken, Japan.
RECALLED BY
Toshiba America Medical Systems, Inc., Tustin, California, by 
letter dated November 24, 1999.  Firm-initiated field correction 
ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
60 units were distributed.
REASON
The wheel caster welds can fail causing the caster to fall off, 
resulting in the machine tilting and/or falling.
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PRODUCT
VasoSeal ES (tm) (Extravascular Security) Device Sterile-
Nonpyrogenic.  Recall #Z-327-0.
CODE
Code: 06309241; Expiration Date: 07-01
Sterilization Date: 07-99; Catalog No. 76000.
MANUFACTURER
Datascope, Collagen products Division, Montvale, 
New Jersey.
RECALLED BY
Manufacturer, by telephone followed by letter on September 7, 
1999.  Firm-initiated recall complete.
DISTRIBUTION
Nationwide and Puerto Rico.
QUANTITY
1,165 devices were distributed; firm estimates none remains on 
the market.
REASON
Some units may contain out of specification locator components.
_______
UPDATE
Soflex UC-Absorbing Silicone PC Intraocular Lenses which appeared 
in the November 3, 1999 Enforcement Report is being updated.  It 
should be noted that Model L151U 
(Recall Z-066-0) is not under recall.
PRODUCT
Model LI61U Soflex UV-Absorbing Silicone PC IOL.
Recall #Z-067-0.  
CODE
Lot Numbers 390T, 4BG1, 4BG7, 4CRA and 4DV1 and 4BGB, 4CPB, 4CTJ, 
4CUP, 4CUU, 4E2U, 4EN3, 4EPD, 4ERX, 4FUB.
RECALLED BY
Manufacturer, by letters on September 14, 1999, and October 25, 
1999.  Firm-initiated recall ongoing.

RECALLS AND FIELD CORRECTIONS:  VETERINARY PRODUCTS -- CLASS II
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PRODUCT
First Proof Medicated Shampoo for Dogs, Cats and Horses, in 8-
ounce, 16-ounce and 64-oounce containers: Containing 3% 
chlorhexidine gluconate.  Recall #V-061-0.
CODE
Lot #W9112A.
MANUFACTURER
Virbac, Fort Worth, Texas.
RECALLED BY
Manufacturer, by letter and telephone on November 2, 1999.  Firm-initiated 
recall ongoing.
DISTRIBUTION
Undetermined.
QUANTITY
19,356 8-ounce, 5,040 16-ounce, and 239 gallon bottles were distributed.
REASON
Retained sample was contaminated with bacterial species Burholderia 
cepacia.