FDA

Enforcement Report

December 20, 2000                                                 00-51                     

RECALLS AND FIELD CORRECTIONS:  FOODS -- CLASS I
________
PRODUCT
Fresh Green Leaf Lettuce, packed 24 heads per cardboard carton.  
Recall #F-115-1.
CODE
Lot 012617 on bar code.
GROWER
Freitas Brothers, Nipomo, California.
HARVESTER
Byrd Farms, Guadalupe, California (responsible firm).
RECALLED BY
FreshKist Product, LLC, Santa Maria, California, by telephone on 
September 13 and 14, 2000, followed by letters dated September 14, 2000.  
Firm-initiated recall complete.
DISTRIBUTION
Arizona, California, Connecticut, Florida, Kentucky, Missouri, North 
Carolina, New York, South Carolina, Tennessee, Texas, District of 
Columbia.
QUANTITY
2,516 cartons (24 units per carton) were distributed.
REASON
Product was contaminated with Salmonella.
________
PRODUCT
Ben & Jerry's Peanut Butter Cup Ice Cream, pint size.  Recall #F-116-1.
CODE
Product dated BEFORE October 26, 2001.
MANUFACTURER
Ben & Jerry’s Homemade, Inc., St. Albans, Vermont, and Waterbury, 
Vermont.
RECALLED BY
Ben & Jerry’s Homemade, Inc., South Burlington, Vermont, by press release 
and letter on October 27, 2000.  A follow-up notification was sent on 
November 3, 2000.  Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
8,000 gallons were distributed.
REASON
Product contains undeclared tree nuts.
________
PRODUCT:
Thyroid Synergy Dietary Supplement, in 90-capsule bottles.  
Recall #F-121-1.
CODE
Lot 011191-1191.
MANUFACTURER
Advanced Manufacturing System, Boulder, Colorado.
RECALLED BY
Designs for Health, Boulder, Colorado, by telephone on August 7-8, 2000, 
followed by letter August 10, 2000.  Firm-initiated recall complete.
DISTRIBUTION
Nationwide.
QUANTITY
360 90-capsule bottles were distributed.
REASON
Product contained approximately 225 times the amount of selenium declared 
on label.

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS II
________
PRODUCT
Teriyaki Flavored Hot Smoked Salmon, vacuum packaged.
Recall #F-119-1.
CODE
2640T.
MANUFACTURER
Kasilof Fish Company, Marysville, Washington.
RECALLED BY
Manufacturer, by letter dated October 6, 2000.  
Firm-initiated recall complete.
DISTRIBUTION
Washington State.
QUANTITY
50-60 pounds per week were distributed.
REASON
Product contained undeclared soybeans and wheat.
________
PRODUCT
Dried Shrimp under the following labels:
Shirakiku brand U.S. Dried Shrimp in 1-ounce bags;
Mum's brand U.S. Dried Shrimp in 1-ounce bags; Barre brand Dried Shrimp 
in Bulk 50 lb. Bags.  Recall #F-120-1.
CODE
None.
REPACKER
Nishimoto Trading Company Hawaii, Ltd., Honolulu, Hawaii.
RECALLED BY
Repacker, by letter sent on November 8, 2000.  Firm-initiated recall 
ongoing.
DISTRIBUTION
Hawaii.
QUANTITY
2,725 packages were distributed.
REASON
Product contains undeclared sulfites.

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS I
________
PRODUCT
Etodolac Capsules (Lodine Capsules), 300 mg, in 100-unit bottles, Rx used 
for arthritis and pain management.
NDC #59911-3607-1. Recall #D-057-1.
CODE
Lot #9991052 EXP 7/02.
MANUFACTURER
Wyeth-Ayerst Company, Guayama, Puerto Rico.
RECALLED BY
Wyeth-Ayerst Laboratories, Philadelphia, Pennsylvania, by letter and 
press release on October 5, 2000.  Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
Approximately 935 units were distributed.
REASON
Cross contamination with Acebutolol Hydrochloride, a beta-blocker drug.

END OF ENFORCEMENT REPORT FOR DECEMBER 20, 2000.

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