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
09/23/1992
RECALLS AND FIELD CORRECTIONS: September 23, 1992
FOODS -- CLASS I
92-39
PRODUCT Ready To Eat Sandwiches under Mrs. Drake and Good 'N Fresh
Labels:
Mrs. Drake's Sandwiches:
1. Roast Beef, 3-3/4 ounces;
2. Roast Beef w/Lettuce & Tomato, 5 ounces;
3. Luncheon Meat & Pickle, 3-3/4 ounces;
4. Roast Beef & Gravy, 6 ounces;
5. Luncheon Meat & Cheese, 3-3/4 ounces;
6. Sliced Turkey, 3+ ounces;
7. Turkey, Lettuce & Tomato, 5 ounces;
8. Super Sub, 7+ ounces;
9. Luncheon Meat & Potato Salad, 4 ounces;
Good 'N Fresh Sandwiches:
10. Ham & Swiss Dressed, 9 ounces;
11. Roast Beef Dressed, 10 ounces;
12. Luncheon Meat & Cheese, 4 ounces;
13. Chicken Salad, 3+ ounces;
14. Tuna Salad, 3+ ounces;
15. Chicken Salad on Rye, 3+ ounces;
16. Ham 'N' Cheese, 4+ ounces;
17. Roast Beef 3+ ounces;
18. Ham 'N' Swiss on Rye, 4 ounces;
19. Turkey, 3-3/4 ounces;
20. Egg Salad, 3+ ounces;
21. Ham 'N' Cheese, 5 ounces;
22. Super Combo, 6 ounces;
23. Double Burger 'N' Cheese, 6 ounces;
24. Hickory Smoked BBQ Beef, 6+ ounces;
25. Crispy Fish Fillet, 4+ ounces;
26. Grilled Chicken Breast, 4-3/4 ounces;
27. Muffuletta, 7 ounces. Recall #F-498/521-2.
CODE Pull dates 6/26/92 and earlier.
MANUFACTURER Mrs. Drake' Sandwiches, New Orleans, Louisiana.
RECALLED BY Manufacturer, by letter June 18, 1992. Firm-initiated recall
complete.
DISTRIBUTION Louisiana.
QUANTITY Firm estimates none remains on the market.
REASON Products were contaminated with Listeria monocytogenes.
PRODUCT (a) Ready-to-eat Special Crabmeat, in 16 ounce containers;
(b) Ready-to-eat Claw Crabmeat, in 1 pound and 5 pound plastic
containers. Recall #F-541/542-2.
CODE "7 5".
MANUFACTURER Keyser Brothers, Inc., Lottsburg, Virginia.
RECALLED BY Manufacturer, by telephone July 16 & 17, 1992, and by letter
July 17, 1992. Firm-initiated recall complete.
DISTRIBUTION Maryland, Virginia.
QUANTITY (a) 180 pounds; (b) 493 pounds were distributed.
REASON Product contaminated with Listeria monocytogenes.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
PRODUCT (a) Hershey's Chocolate Shoppe Hot Fudge Topping, in 18 ounce
glass jars;
(b) Hershey's Chocolate Shoppe Double Chocolate Fudge Topping,
in 18.5 ounce glass jars. Recall #F-490/491-2.
CODE Lot numbers: (a) 28A--, 28B--, 28F--, 28R--, 28S--;
(b) 28H--, 28J--. Products have a five digit code. The first
two digits being 28 followed by a letter which represents the
day it was manufactured and the last two digits are numerical
digits representing the military time it was manufactured in
hundreds. This code is followed by FEB 93.
MANUFACTURER Piknik Products Company, Inc., Montgomery, Alabama.
RECALLED BY Hershey Chocolate USA, Hershey, Pennsylvania, by letter July
16, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Venezuela.
QUANTITY (a) 28,455 cases (12 jars per case); (b) 10,150 cases (12 jars
per case were distributed.
REASON Products contain pieces of glass.
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PRODUCT Janet Lee brand Canned Pieces & Stems Mushrooms, 4 ounces.
Recall #F-544-2.
CODE MSP FCY 1302, MSP FCY 1303, MSP FCY 1304, MSP FCY 1305.
MANUFACTURER Grown and packed in Taiwan, R.O.C.
RECALLED BY Albertson's, Inc., Boise, Idaho, by letter June 22, 1992.
Firm-initiated recall complete.
DISTRIBUTION Texas, Louisiana, Arkansas, Kansas, Nebraska.
QUANTITY 40 cases (24 cans per case) were distributed.
REASON Product is contaminated with Staphylococcal enterotoxin.
PRODUCT Elliot's Amazing Apple Juice, in 12 ounce glass bottles.
Recall #F-545-2.
CODE S1354E 0500 through S1354E 0530.
MANUFACTURER Chesapeake Beverage Corporation, Havre de Grace, Maryland.
RECALLED BY Ginger Group, Ltd., Jenkintown, Pennsylvania, by letter July
17, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Virginia, Pennsylvania, Rhode Island, New Jersey, New York,
Maryland.
QUANTITY 3,816 cases (24 bottles per case) were distributed.
REASON The product is contaminated with a high alkaline chemical
solution.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
PRODUCT Pure Granulated Sugar in 2, 5, and 10 pound bags, under the
Thrifty Maid, Colonial, White Gold, Town House, Shurfine and
A & P labels. Recall #F-494-2.
CODE Lot numbers: C-156-C1, C-156-C2, C-156-C3, C-157-C1, C-157-C2,
C-157-C3.
MANUFACTURER Colonial Sugar Company, Gramercy, Louisiana.
RECALLED BY Savannah Foods & Industries, Inc., Savannah, Georgia, by letter
July 14, 17, and 20, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Alabama, Arkansas, Florida, Kentucky, Louisiana, Maryland,
Mississippi, North Carolina, Pennsylvania, Tennessee, Texas,
Virginia, West Virginia, Washington, D.C., Canada.
QUANTITY 12,159.50 pounds were distributed.
REASON Product is contaminated with metal particles.
PRODUCT Diet Coke, in 12 fluid ounce cans, in 16 fluid ounce bottles,
and in 2 liter bottles. Recall #F-543-2.
CODE Lot numbers: 2206K21 (12 ounce cans bottles), 2205K22 (16
ounce bottles); 2205K23 (2 liter bottles).
MANUFACTURER Magnolia Coca-Cola Bottling Company, El Paso, Texas.
RECALLED BY Manufacturer, by telephone August 14, 1992, followed by visit.
Firm-initiated recall ongoing.
DISTRIBUTION Texas, New Mexico, Arizona.
QUANTITY Firm estimates none remains on the market.
REASON Product contains saccharin and saccharin is not listed as an
ingredient.
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RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
UPDATE Ibuprofen Tablets, Recall #D-456-2, manufactured by Boots
Pharmaceuticals, which appeared in the August 19, 1992
Enforcement Report is the Rx drug.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- Class II
PRODUCT (a) English Plantain Allergenic Extract, in 50 ml vials;
(b) English Plantain Allergenic Extract, in a 30 ml vial;
(c) Custom Weed Mix Allergenic Extract, in a 50 ml vial.
Recall #B-330/332-2.
CODE Lot numbers: 54-68-2A1; (b) 54-68-2A2; (c) PO275-70-1A1.
MANUFACTURER Greer Laboratories, Inc., Lenoir, North Carolina.
RECALLED BY Manufacturer, by telephone May 7, 1992. Firm-initiated recall
complete.
DISTRIBUTION North Carolina, South Carolina, Connecticut, Oregon, Kentucky,
Florida, Kansas, Texas.
QUANTITY (a) 19 vials; (b) 1 vial; (c) 1 vial. Firm estimates none
remains on the market.
REASON Allergenic extracts, labeled with the incorrect type of
allergen, were distributed.
PRODUCT Platelets, Expired. Recall #B-445-2.
CODE Unit numbers: 8198980, 8198988, 8277426, 8284774, 8284790,
8299489, 8299897, 8300611, 8300623, 8301233, 8301242, 8302325.
MANUFACTURER The Blood Center for Southeast Louisiana, New Orleans,
Louisiana.
RECALLED BY Manufacturer, by letter April 15, 1992. Firm-initiated recall
complete.
DISTRIBUTION Florida.
QUANTITY 12 units.
REASON Blood products, which contained a unit that tested repeatedly
reactive for the antibody to human immunodeficiency virus type
1 (anti-HIV-1), were distributed.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
PRODUCT Red Blood Cells, Leukocytes Removed. Recall #B-446-2.
CODE Unit numbers: 8277328, 8277329, 8277331, 8277344, 8289290,
8289304, 8289488, 8289493, 8289496, 8289497.
MANUFACTURER The Blood Center for Southeast Louisiana, New Orleans,
Louisiana.
RECALLED BY Manufacturer, by telephone on or about March 5, 1992.
Firm-initiated recall complete.
DISTRIBUTION Alabama.
QUANTITY 10 units.
REASON Blood products that were unlicensed and entered into interstate
commerce were distributed.
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RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
PRODUCT Love-Gruenwald Rongeur Forceps, 7" shaft, 2 mm x 10 mm cup, a
stainless steel surgical instrument used for scraping soft
tissue during surgery. Recall #Z-1262-2.
CODE Catalog numbers: NL6146 - straight, NL6147 - angled up, NL6148
- angled down. Lot numbers: XMMB and XMMD.
MANUFACTURER Franz Maier, Gosheim, Germany.
RECALLED BY Baxter Healthcare Corporation, Niles, Illinois, by letter May
19, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Arkansas, Colorado, Canada, Italy.
QUANTITY 336 units were distributed; firm estimates that 90 percent of
the units remain on the market.
REASON The jaws of the forceps may break during usage.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
PRODUCT (a) Group B Streptococcus Latex Kit, Catalog #40846;
(b) Streptococcus Grouping Kit, Catalog #40842; used for
diagnosis of streptococcus. Recall #Z-1290/1291-2.
CODE Lot numbers: (a) K1GIGS; (b) C1HFJG, J1HFKE.
MANUFACTURER Becton Dickinson Microbiology Systems, Cockeysville, Maryland.
RECALLED BY Manufacturer, by letter June 17, 1991 and July 15, 1991.
Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY (a) 61 kits; (b) 294 kits were distributed; firm estimates none
remains on the market.
REASON Labeling error -- the label incorrectly states that the "B"
component contains Group A Streptococcus Antibody Coated Latex,
when, in fact, it does contain Group B Streptococcus Antibody
Coated Latex.
MASS SEIZURE:
PRODUCT Various Frozen Shrimp and Fish Products (92-661-450).
CHARGE Adulterated - the products consist in part of decomposed
seafood, or they are otherwise unfit for food because they
are rancid, freezer burned, or dehydrated.
FIRM Impex Shrimp and Fish Company, Inc., Elk Grove Village,
Illinois.
FILED August 17, 1992 - U.S. District Court for the Northern
District of Illinois, Eastern Division; Civil #92-C-5507,
FDC #66500.
SEIZED August 17, 1992 - goods valued at approximately $50,000.
SEIZURES:
PRODUCT Chunk Light Tuna in Oil (92-608-056).
CHARGE Adulterated - the product consists in part of decomposed
tuna fish; and the product is pet food which had been
relabeled as human food, thus concealing its inferiority.
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Misbranded - the product is offered for sale under the name
of another food.
FIRM John's Railroad Salvage Warehouse, Chattanooga, Tennessee.
FILED August 26, 1992 - U.S. District Court for the Eastern
District of Tennessee, Southern Division; Civil
#CIV-1-92-406, FDC #66472.
SEIZED September 2, 1992 - goods valued at approximately $8,151.
PRODUCT Chunk Light Tuna Fish (92-608-057).
CHARGE Adulterated - the product consists in part of decomposed
tuna fish; and the product is pet food which has been
relabeled as human food, thus concealing its inferiority.
Misbranded - The product is offered for sale under the name
of another food.
FIRM Bargain Barn, Inc., Etowah, Tennessee.
FILED August 26, 1992 - U.S. District Court for the Eastern
District of Tennessee, Southern Division; Civil #CIV-1-92-
407, FDC #66492.
SEIZED September 2, 1992 - goods valued at approximately $2,730.
PRODUCT Salted pollock fillets (92-667-395).
CHARGE Adulterated - the product consists in part of decomposed
fish and is unfit for food due to rancidity.
FIRM Casera Foods, Inc., Barceloneta, Puerto Rico.
FILED July 30, 1992 - U.S. District Court for the District of
Puerto Rico; Civil #92-2049(JP), FDC #66483.
SEIZED August 26, 1992 - goods valued at approximately $57,950.
PRODUCT Evening primrose oil (88-233-183, et al).
CHARGE Adulterated - the products contain Oil of Evening Primrose,
a food additive which is unsafe because there is no
regulation in effect prescribing the conditions under which
it may be safely used.
FIRM Murdock Health Care, doing business as: Nature's Way
Products, Inc., Nutrition Professionals, Inc., Murdock
Pharmaceuticals, Inc., and other associated and related
firms, Springville and Provo, Utah.
FILED July 1, 1992; U.S. District Court for the District of
Utah, Central Division; Civil #92-C-0584B, FDC #66473.
SEIZED July 2, 1992 - goods valued at approximately $1.7 million.
PRODUCT Mako shark and black tip shark (92-556-040/053).
CHARGE Adulterated - the products contain an added poisonous and
deleterious substance, methyl mercury, which may render them
injurious to health.
FIRM Harry H. Bell and Sons, Inc., St. Petersburg, Florida.
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FILED May 1, 1992 - U.S. District Court for the Middle
District of Florida, Tampa Division; Civil #92-584CIVT-
21(B), FDC #66421.
SEIZED May 7, 1992 - goods valued at approximately $1,335.
PRODUCT Oral clinical thermometers (92-662-101).
CHARGE Adulterated - the quality of the product falls below that
which it purports and is represented to possess.
Misbranded - The labeling of the product is false and
misleading because it does not meet the specifications
stated on the label.
FIRM Cypress Medical Products, McHenry, Illinois.
FILED June 8, 1992 - U.S. District Court for the Northern District of
Illinois, Western Division; Civil #92C20170, FDC #66429.
SEIZED June 11, 1992 - 1,440 thermometers valued at approximately $800.
INJUNCTION:
PRODUCT Fish (92-683-683).
CHARGE Adulterated - the articles contained a poisonous or
deleterious substance, Listeria monocytogenes, and was
packed, prepared, or held under insanitary conditions
whereby it may have been rendered injurious to health.
DEFENDANTS: Smoky BBQ Fish Company, Long Beach, California,
and Sun Euk Cho, Danny Cho, and Bert Markovitz,
Long Beach, California.
FILED August 14, 1992 - U.S. District Court for the Central District
of California; Civil #92 4900 MRP, INJ 1304.
DISPOSITION A consent decree was signed by all parties with provisions
requiring that the defendants ensure that adequate methods,
facilities, and controls used for receiving, manufacturing,
processing, smoking, salt-curing, preparing, packing,
labeling, and holding food in the facility are established
and implemented so that food is not contaminated with
Listeria monocytogenes, Clostridium botulinum, or any other
pathogenic organism.
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END OF ENFORCEMENT FOR September 23, 1992. BLANK PAGES MAY FOLLOW
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