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U.S. Department of Health and Human Services

Animal & Veterinary

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FDA STOPS IMPORTATION AND DISTRIBUTION OF CONTAMINATED ANIMALS DRUGS

FDA Veterinarian Newsletter May/June 1999 Volume XIV, No III

Two California firms have agreed to stop manufacturing and importing injectable animal drugs after the Food and Drug Administration had found their products to be contaminated and to pose a health hazard to treated animals and to consumers of foods from animals.

The ban on distribution and importation is part of a consent decree entered by the United States District Court for the Eastern District of California by Sierra Pharmaceutical Inc., whose plant in Mexicali, B.C., Mexico, manufactured the drugs, and Veterinary Pharmaceuticals, Inc., a sister company that imported and distributed Sierra's products in the U.S. Both firms are based in Hanford, California.

The FDA identified the potential public health hazard in the fall of 1997, after the agency's investigators in California and Kansas collected samples of 45 lots of Sierra's injectable drugs and submitted them for analyses to FDA laboratories in San Francisco and Seattle.

Nine of the lots, which were labeled "sterile," were found to be contaminated with various types of bacteria, including Bacillus cereus, B. licheniformis, B. sphaericus and B. subtilis, and most of the samples contained alcohol as preservative, although they were represented as "preservative free". The detected bacteria can cause such diseases as blood poisoning, respiratory infections and mastitis in dairy cows, and produce toxins that remain in the animal tissue. As a contaminant on food, these pathogens can cause nausea, vomiting and diarrhea in people.

According to a report received by FDA from a California veterinarian, animals in several dairy herds had suffered illnesses attributable to the Sierra products. After remedial actions repeatedly promised by the firm were not carried out, FDA placed an import alert on Sierra's drugs in order to prevent any Sierra products from entering the U.S.

Since then, Sierra has informed FDA that it has sold all of its assets and that it is in the process of dissolution and winding up all corporate affairs. Under the permanent injunction, the firm may only resume distribution of its drugs in the U.S. following an FDA inspection of Sierra's manufacturing facilities in Mexico and a finding that they are in compliance with U.S. laws.