FDA
Enforcement Report
The FDA Enforcement Report is published weekly by the Food and Drug
Administration,
U.S. Public Health Service, Department of Health and Human Services. It contains
information
on actions taken in connection with agency regulatory activities.
ENFORCE
08/29/1995
ENFORCEMENT REPORT for 08/30/1995
August 30, 1995
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
==========================
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PRODUCT Tostitos brand Restaurant Style Salsa Con Queso (cheese
dip), in 10 3/4 ounce glass jars with button top lids,
Recall #F-764-5.
CODE 23 Nov 95 X20 23:06 through 23 Nov 95 X20 00:36.
MANUFACTURER Mid-America Dairymen, Inc., Schulenburg, Texas.
RECALLED BY Frito-Lay, Inc., Plano, Texas, by facsimile May 6, 1995.
Firm-initiated recall complete.
DISTRIBUTION Oregon.
QUANTITY None remains on market.
REASON The product has the potential to support the outgrowth of
Clostridium botulinum toxin.
_______________
PRODUCT Sliced Norwegian Smoked Salmon, packed in clear plastic
packages, Recall #F-765-5.
CODE Lot #3178.
MANUFACTURER Intersea Fisheries, Ltd., Teaneck, New Jersey.
RECALLED BY Homarus, Inc., Mt. Kisco, New York, by facsimile and letter
June 28, 1995, with follow-up visit on July 31, 1995.
DISTRIBUTION Virginia.
QUANTITY 5 cases were distributed.
REASON The product is contaminated with Listeria monocytogenes.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
=========================
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PRODUCT Cotton candy labeled in part "FAT FREE FLUFFY STUFF COTTON
CANDY, packaged in 1.5 ounce and 2 ounce plastic bags,
Recall #F-767-5.
CODE All products are being recalled. The firm does not have lot
numbers on its products.
MANUFACTURER O'Tec, Inc., Hyattsville, Maryland.
RECALLED BY Manufacturer, by telephone on or about August 1 & 2, 1995.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 800 cases were distributed.
REASON The product is contaminated with undeclared FD&C Yellow No.
5.
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PRODUCT Ground Nutmeg packaged under the Tone's Heart-Loc and Rykoff
Sexton Connoisseur labels; packaged in 16 ounce and 70 ounce
pacages; Recall #F-768-5.
CODE 4J08, 4J13, 4J15, 4J16, 4J24.
MANUFACTURER Tone Brothers, Inc., Des Moines, Iowa.
RECALLED BY Tone Brothers, Inc., Ankeny, Iowa, by fax October 21, 1994.
Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 11,509 pounds of ground nutmeg.
REASON The product is contaminated with aflatoxin.
RECALLS AND FIELD CORRECTION: FOODS -- CLASS III
=======================
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PRODUCT Lehmann Farms Marinated Green Beans in 16 ounce glass jars,
Recall #F-769-5.
CODE Lot #62781.
MANUFACTURER Mr. Berns & Company, Lehmann Farms, Spring Park, Minnesota.
RECALLED BY Manufacturer, by memorandums dated July 3, 1995. Firm-
initiated recall complete.
DISTRIBUTION Minnesota, Colorado, Illinois, Virginia.
QUANTITY 63.25 cases were distributed.
REASON The product is contaminated with putrefactive anaerobes and
flat sour spores (spoilage organisms).
-2-
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PRODUCT Stilwell brands Frozen fruit cobblers in two pound
containers, Recall #F-773/778-5.
CODE All lots produced between June 5, 1995, and July 18, 1995.
MANUFACTURER Stilwell Foods, Inc., Stilwell, Oklahoma.
RECALLED BY Manufacturer, by telephone July 19, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 38,463 cases were distributed. Firm estimates none remain
on market.
REASON The product contains small metal pieces.
_______________
PRODUCT a) Aseptically packed whole milk, and 2% milk in "Tetra Pak"
cartons, Recall #F-779/780-5.
CODE "RN25CM*2", where the *denotes a letter from A-Z;
"RP25CL*2", where the * denotes a letter from H-K.
MANUFACTURER Real Fresh, Inc., Visalia, California.
RECALLED BY Manufacturer, by telephone May 2, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION California, Hawaii, Oregon, Washington state.
QUANTITY 4,621 cases were distributed.
REASON The products are contaminated with Bacillus cereus which
causes a bitter off flavor rendering them unfit for food.
_______________
PRODUCT Green Giant Cut Leaf Spinach packaged in 1 pound plastic
bags, Recall #F-781-5.
CODE E5S12A3.
MANUFACTURER Del Mar Food Products Corporation, Watsonville, California.
RECALLED BY The Pillsbury Company, Minneapolis, Minnesota, by electronic
mail August 3, 1995. Firm-initiated recall ongoing.
DISTRIBUTION Colorado, Oklahoma, Texas, Louisiana, Missouri.
QUANTITY 650-12/1 pound bag per case were distributed.
REASON The product contains parts of a rodent.
_______________
PRODUCT A Whale of a Snack fat free fruit bars manufactured in
flavors blueberry, apple, fig, and strawberry, Recall #F-
782/785-5.
CODE All products manufactured between December 1, 1994 and March
11, 1995. Codes would be 01 May 95 through 11 Sep 95.
-3-
MANUFACTURER Fleetwood Snacks, Inc., Fleetwood, Pennsylvania.
RECALLED BY Manufacturer, by telephone June 28, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Firm estimates none remain on the market.
REASON The product is contaminated with plastic pieces.
_______________
PRODUCT Mojo Criola, a Spanish marinating sauce in 24 ounce glass
bottle, Recall #F-786-5.
CODE No manufacturing codes on label.
MANUFACTURER La Lechonera Products, Inc., Miami, Florida.
RECALLED BY Manufacturer, on or about July 17, 1995. Firm-initiated
recall complete.
DISTRIBUTION Florida
QUANTITY Firm estimates none remain on the market.
REASON The product is contaminated with sand.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
======================
______________
PRODUCT Materna, prenatal vitamin and mineral tablets, 100 tablets
per bottle, an Rx drug used as a nutritional supplement for
pregnant or lactating women, Recall #D-238-5.
CODE Control #384-420, exp. date February 1996, NDC #0005-5560-
23.
MANUFACTURER Lederle Laboratories, Division of American Home Products,
Inc., Pearl River, New York.
RECALLED BY Manufacturer, by letter August 7, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 14,046 bottles of 100 tablets were distributed.
REASON Products does not meet potency specification for Vitamin A
and Vitamin D ingredients.
______________
PRODUCT (a) Toxavit, 2g in glass bottle, product is a dental paste
containing paraformaldehyde, lidocaine hydrochloride, and m-
cresol as active ingredients, used in devitalization of
dental pulp before extirpation; (b) Socketol 5g, product is
a dental paste containing phenylmercuric acetate, used in
the treatment and prevention of post extraction pain, Recall
#D-239/240-5.
-4-
CODE All lots.
MANUFACTURER Lege Artis Pharma GmbH + Co. KG, Dettenhausen, Germany.
RECALLED BY Medidenta International Inc., Woodside, New York by letter
August 12, 1995. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Firm estimates none remains on market.
REASON Product was marketed without new drug approval.
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PRODUCT Triamcinolone Acetonide Ointment, USP 0.1%, in 80 gram
tubes, a prescription topical corticosteroid indicated for
the relief of flammatory and ruritic skin conditions.,
Recall #D-241-5.
CODE Lot #J710 exp. date 12/96,
MANUFACTURER Thames Pharmacal Company, Inc., Ronkonkoma, New York.
RECALLED BY Manufacturer, by letter May 16, 1995. Firm-initiated recall
complete.
DISTRIBUTION Florida, Michigan, Georgia, New York, Illinois, Alabama,
Kentucky, Washington state.
QUANTITY 1,594 tubes were distributed.
REASON Potency not assured through expiration date.
______________
PRODUCT Ponstel Capsules, mefenamic acid, an Rx oral nonsteroidal
anti-inflammatory, analgesic and antipyretic drug used for
the relief of moderate pain, Recall #D-242-5.
CODE Lot #'s 3208102, 2074084, 2021011, 2048021, 1213093,
1193005, 1175058, 3098067, 3075043, 3067099, 3019036,
2015064, 2006310, 1246001, 1241064.
MANUFACTURER Warner Lambert Company, Fajardo, Puerto Rico.
RECALLED BY Allscrips Pharmaceuticals Inc. (repacker), Vernon Hills,
Illinois, by letter August 14, 1995. Firm-initiated recall
ongoing.
DISTRIBUTION Alabama, Vermont, California, Hawaii, New Jersey, Indiana,
North Carolina, Maryland, Florida, Iowa, Pennsylvania.
QUANTITY 285 bottles were distributed.
REASON Manufacturer initiated withdrawal of new drug approval site
supplement.
-5-
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END OF ENFORCEMENT REPORT FOR AUGUST 30, 1995. BLANK PAGES MAY
FOLLOW.