P98-2 FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE Print Media: 301-827-6242
January 16, 1998
Consumer Inquiries: 800-532-4440
The agency urges anyone who has purchased these products 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 SolutionLactated Ringer's Solution
Calcium Gluconate 23% Solution
Dextrose Solution 50%
Electrolyte Solution w/ Dextrose.
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.