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U.S. Department of Health and Human Services

Animal & Veterinary

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WARNING ON CONTAMINATED VETERINARY DRUGS

FDA Veterinarian Newsletter March/April 1998 Volume XIII, No II

The Food and Drug Administration issued a national warning against the use of all large volume parenteral drugs distributed by Veterinary Pharmaceuticals, Inc., (VPI) of Hanford, California, and manufactured by its subsidiary, Sierra Pharmaceuticals, Inc., of Mexicali, Mexico. The company has recalled these drugs, commonly used to treat dairy cows, because they are contaminated with bacillus cereus bacteria -- bacteria that can cause severe injury and death in cows.

The Agency urges anyone who has these products on hand to immediately stop using them. The Agency has also issued an Import Alert to prevent the importation of these products. FDA analyses show that samples of the following drugs manufactured by this company are contaminated with bacillus cereus bacteria or related bacteria species:

  • Hypertonic Saline Solution
  • Lactated Ringer's Solution
  • Calcium Gluconate 23% Solution
  • Dextrose Solution 50%
  • Electrolyte Solution w/ Dextrose
  • Caldex CMPK
  • Sterile Water for Injection
  • Vitamin B Complex
  • Vitamin B Complex Fortified

Since Sierra Pharmaceuticals used common equipment, manufacturing practices, and controls for the above drugs and all other large volume parenteral products it manufactured, all large volume parenteral veterinary drugs manufactured by Sierra Pharmaceuticals, Inc., and distributed by Veterinary Pharmaceuticals Inc., are covered by this warning.

Those who may have existing stocks of these drugs should contact the distributorship from where they were purchased for instructions on what to do with these products. Purchasers may also want to consult their veterinarians if they have treated any cows with these products.