Pfizer Animal Health voluntarily recalls two medications used for sedation

Madison, N.J.

— Pfizer Animal Health is voluntarily recalling one lot each of Antisedan® (atipamezole hydrochloride) Sterile Injectable Solution and Dexdomitor® (dexmedetomidine hydrochloride) Sterile Injectable Solution after it was discovered that some of these products may contain foreign particles.

The foreign particles originate from a glass vial manufacturing defect, according to Pfizer. The affected lots are: Lot 1399276 of Antisedan (expiration: 03-2014) and Lot 1391999 of Dexdomitor (expiration: 01-2014).

Dexdomitor is used as a sedative and analgesic in dogs and cats to facilitate clinical examinations, clinical procedures, minor surgical procedures and minor dental procedures. It is also indicated for use as a preanesthetic to general anesthesia in the dog and cat. Antisedan is indicated for the reversal of the sedative and analgesic effects of Dexdomitor (dexmedetomidine hydrochloride) and Domitor (medetomidine hydrochloride) in dogs, says Pfizer.

According to Pfizer, a scientific assessment determined that use of affected lots of Dexdomitor intravenously could result in serious adverse health consequences. The risk for adverse health events with both drugs is small when intramuscularly, the company says.

Pfizer and its manufacturing partner Orion Corporation immediately decided to implement the recall following discovery of the potential of foreign particle contamination. The companies are contacting known purchases of the affected lots and providing instructions for returning the products to Pfizer.

Questions about the recall should be directed to Pfizer’s Veterinary Medical Information and Product Support (VMIPS) group at (800) 366-5288.