Pfizer Inc.: Antisedan and Dexdomitor Injectable Solutions Recalled for Foreign Particles

Agency Publication Date: November 4, 2011

Summary

Approximately 16,251 vials of Antisedan (atipamezole hydrochloride) and Dexdomitor (dexmedetomidine hydrochloride) veterinary injectable solutions have been recalled. These medications, used as sedatives and reversal agents in animals, may contain foreign particles within the sterile vials. Consumers should check their supplies for Antisedan (10 mL vials) and Dexdomitor (10 mL vials) distributed nationwide.

Risk

The presence of foreign particles in a sterile injectable solution can cause serious health complications in animals, including inflammation, granulomas, or embolism if the particles are injected into the bloodstream.

What You Should Do

Identify affected products by looking for Antisedan (atipamezole hydrochloride) 5.0 mg/mL in 10 mL vials (Recall # V-004-2012) and Dexdomitor (dexmedetomidine hydrochloride) 0.5 mg/mL in 10 mL vials (Recall # V-005-2012).
Immediately stop using any vials from the affected lots and secure them to prevent further administration to animals.
Contact your veterinarian or pharmacist to discuss the recall and arrange for the return of any unused medication.
Return any unused vials to the place of purchase or contact Pfizer Animal Health (now Zoetis) for specific return and refund instructions.
Call the FDA's Center for Veterinary Medicine at 1-240-276-9300 for additional questions regarding this recall.

Your Remedy Options

Full Refund

Product return and refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: ANTISEDAN (atipamezole hydrochloride) Sterile Injectable Solution (10 mL)

Model:

NADA 141-033

V-004-2012

Product: DEXDOMITOR (dexmedetomidine hydrochloride) Sterile Injectable Solution (10 mL)

Model:

NADA 141-267

V-005-2012

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 59955

Status: Resolved

Manufacturer: Pfizer Inc.

Sold By: Pfizer Animal Health; Veterinary distributors

Manufactured In: Finland, United States

Units Affected: 2 products (1,772 bottles; 14,479 bottles)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

Summary

What You Should Do

Identify affected products by looking for Antisedan (atipamezole hydrochloride) 5.0 mg/mL in 10 mL vials (Recall # V-004-2012) and Dexdomitor (dexmedetomidine hydrochloride) 0.5 mg/mL in 10 mL vials (Recall # V-005-2012).

Immediately stop using any vials from the affected lots and secure them to prevent further administration to animals.

Contact your veterinarian or pharmacist to discuss the recall and arrange for the return of any unused medication.

Return any unused vials to the place of purchase or contact Pfizer Animal Health (now Zoetis) for specific return and refund instructions.

Call the FDA's Center for Veterinary Medicine at 1-240-276-9300 for additional questions regarding this recall.