Jun
27
2014

Piramal Critical Care, a global manufacturer of products used in hospitals and emergency rooms, is voluntarily recalling 2,052 glass vials of Petrem, a generic product used for the induction and maintenance of general anesthesia in dogs.

According to Piramal, Petrem is the first generic sevoflurane approved for veterinary use.

The single lot of Petrem is being recalled due to "retained material not meeting the acidity/alkalinity specifications as set forth in the USP Monograph for Sevoflurane," the FDA said.

According to the FDA, Piramal voluntarily began recalling the 250ml bottles in April 2014 under class III, meaning use of or exposure to the product is unlikely to cause adverse health consequences.

Recalled product details

  • Recall number: V-072-2014
  • Code info: lot S2991K16 , exp 11/2016
  • Product description: Petrem, lot S2991K16 Sevoflurane, USP , 250 mL, packaged in an amber glass vial, NDC 60307-320-25, for use in dogs, ANADA 200-438, manufactured by MINRAD, INC., Bethlehem, PA. Piramal Inc is the actual manufacturing site dba as MINRAD, INC. since 2009.
  • Shipping information: Shipped to distributors and physicians in New York, Pennsylvania, North Carolina, Tennessee, Massachusetts, Maine, Iowa, Illinois, Indiana, Mississippi, Florida, Nebraska, Ohio, Oregon, Wisconsin, Missouri, Michigan, Minnesota, and New Jersey.
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