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
01/12/1994
Recalls and Field Corrections: Foods -- Class II -- 01/12/1994
January 12, 1994 94-2
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
=========================
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PRODUCT (a) Shellstock Oysters; (b) Shucked Oysters.
Recall #F-143/144-4.
CODE All product dated 9/8/93 through 11/16/93.
MANUFACTURER Terry's Seafood, Inc., Lakeshore, Mississippi.
RECALLED BY Manufacturer, by telephone Novemer 16, 1993. Firm-initiated
recall ongoing.
DISTRIBUTION North Carolina, Maryland, Virginia, Alabama, Mississippi.
QUANTITY (a) 42,268 sacks; (b) 1,000 gallons.
REASON Oysters harvested at Cabbage Reef and Grand Pass have been
associated with at least 16 discrete outbreaks of
gastroenteritis.
_______________
PRODUCT Processed Fresh Shucked Oysters, packaged in various net
weight sizes. Recall #F-145-4.
CODE All products are coded with sell date between Oct 5 1993 to
Nov 26 1993.
MANUFACTURER Tony V's Oyster, Inc., Amite, Louisiana.
RECALLED BY Manufacturer, by telephone November 24, 1993. Firm-
initiated recall complete.
DISTRIBUTION Alabama, Louisiana.
QUANTITY Firm estimates none remains on the market.
REASON Oysters harvested at Cabbage Reef and Grand Pass have been
associated with at least 16 discrete outbreaks of
gastroenteritis.
_______________
PRODUCT Carvel Ice Cream Desserts:
(a) 8" Round Cake, 50 fluid ounces; (b) 10" Round Cake, 75
fluid ounces; (c) Sheet Cake, 105 fluid ounces; (d) Dessert
Cake, 25 fluid ounces; (e) Barney Cake, 50 fluid ounces; (f)
Cannoli 6 Pack, 6-4 fluid ounces one cannoli shell each (24
fluid ounces plus 6 shells). Recall #F-150/155-4.
CODE All lots.
MANUFACTURER A. Production Facilities (Manufacturer/Wholesale)
Carvel Ice Cream Bakery, Jessup, Maryland;
Carvel Ice Cream Bakery, Moorestown, New Jersey;
Carvel Ice Cream Bakery, Tampa, Florida;
B. Carvel Company Stores (Manufacturer/Retail/Wholesale)
Vineland, New Jersey; Westwood, Massachusetts;
Williamsport, Pennsylvania; Lakeland, Florida;
Miami, Florida; Hampton, Virginia;
Newport News, Virginia; West Hartford, Connecticut;
Glenwood Shops- Unit# 8, Norfolk, Virginia;
Aston, Pennsylvania; Brandon, Florida;
New Haven, Connecticut;
RECALLED BY Carvel Ice Cream Bakery, Farmington, Connecticut, by letter
November 19, 1993. Firm-initiated recall complete.
DISTRIBUTION Massachusetts, Connecticut, Rhode Island, New York,
Delaware, New Jersey, Pennsylvania, Maryland, North
Carolina, Virginia, Florida, Puerto Rico.
QUANTITY Firm estimated approximately 20,000 units remained on the
market at time of recall.
REASON Products contain undeclared FD&C Yellow No. 5.
_______________
PRODUCT Raw Asparagus, in 11 pound wooden crates. Recall #F-157-4.
CODE 01 or 06 (grower number).
MANUFACTURER Comercializadora Plantagro Ltd., Linnares, Chile (grower).
RECALLED BY Mo-Bo Enterprises, Pompano Beach, Florida, by telephone
October 21, 1993, followed by letter. Firm-initiated recall
complete.
DISTRIBUTION Pennsylvania, Florida, New York.
QUANTITY 389 crates were distributed; firm estimates none remains on
the market.
REASON Product contained illegal residues of permetherin.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
========================
_______________
PRODUCT Indian Blanched Cashew Kernels, packaged in 25 pound tins.
Recall #F-050-4.
CODE Lot #4318.
-2- MANUFACTURER M. Abdulrehumankunju, Quilon, South India.
RECALLED BY Specialty Commodities, Inc., Los Angeles, California, by
letter dated May 15, 1993. Firm-initiated recall complete.
DISTRIBUTION Arizona, California, Oregon, Washington state, British
Columbia, Canada.
QUANTITY 700 cases (2 tins per case) were distributed; firm estimates
none remains on the market.
REASON Product was contaminated with insect filth.
_______________
PRODUCT McKenzie's Cut Green Beans, in 32 ounce flexible plastic
bags, frozen. Recall #F-146-4.
CODE G0963A on bags and on cardboard cases (bags have an
additional character indicative of the packaging machine
used in filing G0963A3).
MANUFACTURER Southern Frozen Foods, Montezuma, Georgia.
RECALLED BY Manufacturer, by telephone on or about December 2, 1993,
followed by letter. Firm-initiated recall ongoing.
DISTRIBUTION Georgia, Florida.
QUANTITY 269 cases (12 units per case) were distributed.
REASON Product contains rodent hairs.
_______________
PRODUCT Light Chunk Tuna in Oil, in 16-1/8 ounce cnas.
Recall #F-147-4.
CODE M3CS/M121C.
MANUFACTURER PAN Pacific, Poway, California.
RECALLED BY Nash Finch Company, Minneapolis, Minnesota, by letter
November 18, 1993. Firm-initiated recall complete.
DISTRIBUTION Iowa, Kansas, Minnesota, Nebraska, North Dakota, South
Dakota, Wisconsin.
QUANTITY 17,000 cases.
REASON Product is contaminated with animal hairs.
_______________
PRODUCT Piggly Wiggly Drinking Water, in 1 gallon containers.
Recall #F-148-4.
CODE 6/11/94 7/3/94 7/26/94 8/12/94
6/17/94 7/10/94 7/28/94 8/17/94
6/18/94 7/14/94 7/29/94 8/20/94
6/22/94 7/15/94 7/31/94 8/24/94
6/30/94 7/22/94 8/5/94 8/31/94
8/9/94 9/1/94.
MANUFACTURER Sky King, Inc./Milkco, Inc., Asheville, North Carolina.
RECALLED BY Manufacturer, by telephone and by letter September 10, 1993.
Firm-initiated recall complete.
DISTRIBUTION South Carolina, Georgia, Florida, North Carolina.
QUANTITY 21,391 cases (3 units per case) were distributedl; firm
estimates none remains on the market.
REASON Label states "distilled USP, rather than filtered and had a
USP designation.
-3- _______________
PRODUCT Piggly Wiggly brand Drinking Water, in 1 gallon containers.
Recall #F-149-4.
CODE July 29, 1994, processed plant 37-82.
MANUFACTURER Sky King, Inc./Milkco, Inc., Asheville, North Carolina.
RECALLED BY Manufacturer, by telephone August 23, 1993. Firm-initiated
recall complete.
DISTRIBUTION South Carolina, Georgia, Florida, North Carolina.
QUANTITY 5,604 gallons were distributed; firm estimates none remains
on the market.
REASON Product is contaminated with unidentified particles.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
=========================
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PRODUCT (a) Carbon Dioxide (C02) USP, Rx in steel cylinders sizes D,
E, and G; (b) Carbon Dioxide/Oxygen Mixture, USP, Rx, in
steel cylinders size G. Recall #D-100/101-4.
CODE All lots.
MANUFACTURER Welding and Therapy Service, Inc., Louisville, Kentucky.
RECALLED BY Manufacturer, by telephone December 2, 1993. Firm-initiated
recall complete.
DISTRIBUTION Kentucky, Indiana.
QUANTITY (a) 54 units size E cylinders and 56 units size G cylinders;
(b) 6 units were distributed.
REASON Current good manufacturing practice deficiencies.
_______________
PRODUCT Levothyroxine Sodium Tablets, USP 0.2 mg, in bottles of 100
and 1000, indicated as replacement or substitution therapy
for diminished or absent thyroid. Recall #D-103-4.
CODE Lot H-738.
MANUFACTURER Pharmaceutical Basics, Inc., Denver, Colorado.
RECALLED BY Manufacturer, by letter December 17, 1993. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 506 100-tablet bottles and 3,899 1000-tablet bottles were
distributed.
REASON Potency not assured through expiration date.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
========================
_______________
PRODUCT Erygel (Erthyromycin Topical Gel USP), 2%, in 30 gram tubes,
Rx indicated for the topical treatment of acne vulgaris.
Recall #D-102-4.
CODE Lot #U0186 EXP 5/95.
MANUFACTURER Allergan, Inc., Irvine, California.
RECALLED BY Manufacturer, by letter October 22, 1993. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
-4- QUANTITY 9,689 units were distributed; FDA estimates 3,000 units
remain on the market.
REASON Presence of rust particles.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS I
======================
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Cryoprecipitated
AHF. Recall #B-089/091-4.
CODE Unit #6122002.
MANUFACTURER The Greater New York Blood Program, New York, New York.
RECALLED BY Manufacturer, by letter August 6, 1993. Firm-initiated
recall complete.
DISTRIBUTION New York.
QUANTITY 1 unit of each component.
REASON Blood products, which tested initially reactive for the
antibody to the human immunodeficiency virus type 1 (anti-
HIV-1) and were not retested in duplicate as required by the
manufacturer's instructions, were distributed.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
=====================
_______________
PRODUCT Recovered Plasma. Recall #B-092-4.
CODE Unit #6122002.
MANUFACTURER The Greater New York Blood Program, New York, New York.
RECALLED BY Manufacturer, by letter August 6, 1993. Firm-initiated
recall ongoing.
DISTRIBUTION New York.
QUANTITY 1 unit.
REASON Recovered plasma which tested initially reactive for the
antibody to the human immunodeficiency virus type 1 (anti-
HIV-1) and was not retested in duplicate as required by the
manufacturer's instructions was distributed for further
manufacture.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
======================
_______________
PRODUCT Labeling, promotional material and advertising for
Beltone's Air Conduction Hearing Aids labeling and
promotional literature. Recall #Z-179-4.
Part #52-00735, Profile Consumer Brochure
Part #52-00736, Profile Silent SS
Part #52-00737, Profile Battery Stuffer
Part #52-00746, The Beltone Guide to Better Hearing Brochure
Part #52-00772, 50 Reasons Brochure
Part #52-00777, Prima Consumer Brochure
Part #52-00808, Petite Battery Stuffer
Part #52-00861, Voice Enhancer Banner
Part #52-00862, ClearVoice/Voice Enhancer Poster
Part #52-00863, 4-color ClearVoice/Voice Enhancer Brochure
-5- Part #52-00864, ClearVoice/Voice Enhancer Silent Salesman
Part #52-00865, ClearVoice/Voice Enhancer Postcard
Part #52-00871, Noise and Hearing
Part #52-00889, Jubilee Product Guide
Part #52-00892, Prima Product Guide
Part #52-00896, ClearVoice Circuitry Guide
Part #52-00897, Ode Product Guide
Part #52-00900, Voice Enhancer Product Guide
Part #52-00902, Profile Product Guide
Part #52-00907, 2-color ClearVoice Line Brochure
Part #52-00954, Optima ClearVoice Series Brochure
Part #52-00955, Optima 2000 Postcard
Part #52-00956, Optima ClearVoice Banner
ClearVoice/Voice Enhancer Veloxes and Newspaper
Advertisements:
Part #55-00475, 55-00476, 55-00488, 55-00489, 55-00490,
55-00497, 55-00503, 55-00504, 55-00505, 55-00513,
55-00514, 55-00516, 55-00517, 55-00518, 55-00519,
55-00520, 55-00522, 55-00523, 55-00524, 55-00525,
55-00526, 55-00527, 55-00528, 55-00550, 55-00551,
55-00552, 55-00553, 55-00554
Television Advertisements: code HAT-3-60, HAA-3-60 tapes
CODE All versions of the part numbers listed in item #1 above
with print dates prior to May, 1993.
MANUFACTURER Beltone Electronics Corporation, Chicago, Illinois.
RECALLED BY Manufacturer, by memorandum dated May 6, 1993. Firm-
initiated field correction complete.
DISTRIBUTION Nationwide.
QUANTITY 12,096 pieces of literature were distributed.
REASON Promotional material had misleading claims.
RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS II
===========
_______________
PRODUCT Radix Labs Milk Fever K Sterile Non-Pyrogenic, 500 ml,
(injectable), labeled as a source of sterile injectable
calcium, potassium and dextrose for the treatment of milk
fever in cattle. Recall #V-006-4.
CODE Lot #ROJ006 EXP 7/94.
MANUFACTURER Radix Laboratories, Inc., Eau Claire, Wisconsin.
RECALLED BY Manufacturer, by letter February 26, 1993. Firm-initiated
recall complete.
DISTRIBUTION Iowa, Minnesota, New Jersey.
QUANTITY 1,002 bottles were distributed.
REASON Precipitate matter in the product.
RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS III
==========
_______________
PRODUCT Purina Top-16 Dairy & Cattle Wormer, in 50 pound bags.
Recall #V-004-4.
CODE Lot #F9265.
-6- MANUFACTURER Purina Mills, Inc., Minneapolis, Minnesota.
RECALLED BY Manufacturer, by telephone October 16 & 17, 1993. Firm-
initiated recall complete.
DISTRIBUTION Minnesota, Wisconsin.
QUANTITY 48 bags were distributed.
REASON Product is superpotent in Morantel Tartrate.
_______________
PRODUCT Radix Labs Vitamin B1 (Injectable), 200 mg/ml, in 100 ml
bottles, nutritional supplement for B1 deficiency in bovine.
Recall #V-005-4.
CODE Lot #RIP006.
MANUFACTURER Radix Laboratories, Inc., Eau Claire, Wisconsin.
RECALLED BY Manufacturer, by letter December 31, 1992. Firm-initiated
recall complete.
DISTRIBUTION Minnesota, Pennsylvania, Wisconsin.
QUANTITY 1,039 bottles were distributed.
REASON Precipitate matter in product.
SEIZURE:
==================================================================
_______________
PRODUCTS Lab-Tek and Flaskette Tissue Culture Chamber Slides
(93-661-761).
CHARGE Adulterated - The methods used in, and the facilities and
controls used for, the articles' manufacture, packing, and
storage are not in conformity with current good
manufacturing practice requirements.
FIRM Nunc, Inc., Naperville, Illinois.
FILED December 10, 1993; U.S. District Court for the Northern
District of Illinois, Eastern Division; Civil #93 C7477;
FDC #66719.
SEIZED December 27, 1993 - goods valued at approximately $62,750.
_______________
PRODUCT Canned tuna (93-783-142).
CHARGE Adulterated - The article consists in whole or in part of
decomposed fish.
FIRM Caribe Tuna, Inc., Ponce, Puerto Rico.
FILED November 17, 1993; U.S. District Court for the District
of Puerto Rico; Civil #93-2616-CC; FDC #66783.
SEIZED December 14, 1993 - goods valued at approximately
$19,600.
-7-
END OF ENFORCEMENT REPORT FOR JANUARY 12, 1993. BLANK PAGES MAY
FOLLOW.
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