Medications & Supplements/Veterinary Medicines

Franck's Lab Inc., d.b.a. Franck's Compounding Lab: Sterile Veterinary Injectables Recalled for Fungal and Bacterial Contamination

Agency Publication Date: July 17, 2012

Summary

Franck's Lab Inc. has recalled approximately 4,155 units of various sterile veterinary injectable medications, including Acepromazine, Amikacin, and Buprenorphine, distributed between November 21, 2011, and May 21, 2012. The recall was initiated after FDA environmental testing discovered microorganisms and fungal growth inside the clean room where these sterile products were prepared and compounded. These products were distributed to veterinary clinics and veterinarians by prescription nationwide and internationally.

Risk

The presence of mold and bacteria in injectable medications poses a significant risk of serious infection or illness to animals. Medications meant to be sterile that are contaminated with microorganisms can lead to localized or systemic infections when injected directly into an animal's body.

What You Should Do

Immediately identify if you have any sterile veterinary injectable drugs from Franck's Lab Inc. distributed between November 21, 2011, and May 21, 2012.
Check the prescription (Rx) numbers on your product labels; affected numbers include 0321930, 0348432, 0349124, 0349236, 0349403, and over 1,000 others listed in the recall notice.
Immediately stop using any affected sterile medications and secure them so they cannot be administered to animals.
Contact your veterinarian or healthcare provider to discuss alternative treatments and to report any adverse events in animals that may have received these medications.
Return any unused product to the place of purchase for a refund and contact Franck's Lab Inc. at their Ocala, Florida facility for further instructions.
Contact the FDA Center for Veterinary Medicine for additional questions or to report animal safety concerns.

Your Remedy Options

Full Refund

Veterinary refund and clinical guidance

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

Affected Products

Product: ACEPROMAZINE MALEATE 2MG/ML INJECTABLE (50 ML)

Lot Numbers:

Rx Numbers: See full list in recall record

Date Ranges: Distributed 11/21/2011 - 05/21/2012

Product: ACEPROMAZINE MALEATE 10 MG/ML INJECTABLE (50 ML)

Lot Numbers:

Rx Numbers: See full list in recall record

Date Ranges: Distributed 11/21/2011 - 05/21/2012

Product: ACETYLCYSTEINE 10% INJECTABLE (100 ML)

Lot Numbers:

Rx Numbers: See full list in recall record

Date Ranges: Distributed 11/21/2011 - 05/21/2012

Product: ACETYLCYSTEINE 20% INJECTABLE (30 ML, 50 ML, 90 ML, 100 ML, 120 ML, 180 ML, 200 ML, 300 ML, 400 ML, 600 ML)

Lot Numbers:

Rx Numbers: See full list in recall record

Date Ranges: Distributed 11/21/2011 - 05/21/2012

Product: ACETYL-D-GLUCOSAMINE 10% INJECTABLE (10 ML to 2000 ML)

Lot Numbers:

Rx Numbers: See full list in recall record

Date Ranges: Distributed 11/21/2011 - 05/21/2012

Product: AMIKACIN SULFATE (VET) 250MG/ML INJECTABLE (2 ML to 400 ML)

Lot Numbers:

Rx Numbers: See full list in recall record

Date Ranges: Distributed 11/21/2011 - 05/21/2012

Product: BUPRENORPHINE HCL 0.6MG/ML INJECTABLE (10 ML to 200 ML)

Lot Numbers:

Rx Numbers: See full list in recall record

Date Ranges: Distributed 11/21/2011 - 05/21/2012

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 62111

Status: Resolved

Manufacturer: Franck's Lab Inc., d.b.a. Franck's Compounding Lab

Sold By: Veterinary Clinics; Veterinarians

Manufactured In: United States

Units Affected: 4155

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

Immediately identify if you have any sterile veterinary injectable drugs from Franck's Lab Inc. distributed between November 21, 2011, and May 21, 2012.

Check the prescription (Rx) numbers on your product labels; affected numbers include 0321930, 0348432, 0349124, 0349236, 0349403, and over 1,000 others listed in the recall notice.

Immediately stop using any affected sterile medications and secure them so they cannot be administered to animals.

Contact your veterinarian or healthcare provider to discuss alternative treatments and to report any adverse events in animals that may have received these medications.

Return any unused product to the place of purchase for a refund and contact Franck's Lab Inc. at their Ocala, Florida facility for further instructions.

Contact the FDA Center for Veterinary Medicine for additional questions or to report animal safety concerns.

Affected Products

Product: ACEPROMAZINE MALEATE 2MG/ML INJECTABLE (50 ML)

Lot Numbers:

Rx Numbers: See full list in recall record

Date Ranges: Distributed 11/21/2011 - 05/21/2012

Product: ACEPROMAZINE MALEATE 10 MG/ML INJECTABLE (50 ML)

Lot Numbers:

Rx Numbers: See full list in recall record

Date Ranges: Distributed 11/21/2011 - 05/21/2012

Product: ACETYLCYSTEINE 10% INJECTABLE (100 ML)

Lot Numbers:

Rx Numbers: See full list in recall record

Date Ranges: Distributed 11/21/2011 - 05/21/2012

Product: ACETYLCYSTEINE 20% INJECTABLE (30 ML, 50 ML, 90 ML, 100 ML, 120 ML, 180 ML, 200 ML, 300 ML, 400 ML, 600 ML)

Lot Numbers:

Rx Numbers: See full list in recall record

Date Ranges: Distributed 11/21/2011 - 05/21/2012

Product: ACETYL-D-GLUCOSAMINE 10% INJECTABLE (10 ML to 2000 ML)

Lot Numbers:

Rx Numbers: See full list in recall record

Date Ranges: Distributed 11/21/2011 - 05/21/2012

Product: AMIKACIN SULFATE (VET) 250MG/ML INJECTABLE (2 ML to 400 ML)

Lot Numbers:

Rx Numbers: See full list in recall record

Date Ranges: Distributed 11/21/2011 - 05/21/2012

Product: BUPRENORPHINE HCL 0.6MG/ML INJECTABLE (10 ML to 200 ML)

Lot Numbers:

Rx Numbers: See full list in recall record

Date Ranges: Distributed 11/21/2011 - 05/21/2012