Medications & Supplements/Veterinary Medicines

TEVA Animal Health Inc: Various Animal Penicillin and Griseofulvin Recalled for Quality Violations

Agency Publication Date: April 12, 2010

Summary

TEVA Animal Health Inc. is recalling 272,659 units of various veterinary medications including Procaine Penicillin G, Penicillin G Benzathine, Penicillin G Potassium, and Griseofulvin Powder. These products, sold under several brands such as AmTech, Aspen, and AgriLabs, were not manufactured in compliance with Good Manufacturing Practice (GMP) standards. Because the manufacturing processes did not meet federal requirements, the company cannot guarantee the quality, strength, or purity of the medicine. No injuries or specific animal illnesses have been reported in the provided data, but owners should contact their veterinarian or pharmacist for advice on replacement treatments.

Risk

Failure to follow Good Manufacturing Practices (GMP) means the medication may be contaminated, ineffective, or contain incorrect dosages. Using medications that do not meet quality standards can result in untreated infections in animals or unexpected adverse reactions.

What You Should Do

Identify if you have any of the affected products by checking labels for brand names including AmTech, Aspen, Butler, AgriLabs, durvet, Phoenix, VEDCO, novopharm, or CSR.
Check the specific product type and size: affected items include injectable Penicillin vials in 100-ml, 250-ml, and 500-ml sizes; Penicillin G Potassium in 0.5 or 1.0 billion unit jars; and Griseofulvin Powder in 15-gram pouches.
Immediately stop using the recalled medications on any animals.
Contact your veterinarian or pharmacist for guidance on the health of your animals and to arrange for alternative medications.
Return any unused product to the place of purchase for a full refund and contact TEVA Animal Health Inc. for further instructions.
For additional questions, contact the FDA Center for Veterinary Medicine (CVM) at 240-402-7002.

Your Remedy Options

Full Refund

Product return for refund

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

Affected Products

Product: AmTech Group Inc. Pen-G Max (100-, 250-, 500-ml vials)

Model:

NADA 65-110

Recall #: V-070-2010

Product: Aspen Penicillin G Procaine (100-, 250-, 500-ml vials)

Model:

NADA 65-110

Recall #: V-070-2010

Product: Butler Penject (100-, 250-ml vials)

Model:

NADA 65-110

Recall #: V-070-2010

Product: Phoenix Pharmaceutical, Inc. Pen-G (100-, 250-ml vials)

Model:

NADA 65-110

Recall #: V-070-2010

Product: VEDCO Aquacillin (100-, 250-, 500-ml vials)

Model:

NADA 65-110

Recall #: V-070-2010

Product: novopharm Penicillin G Procaine Injectable Suspension (250-, 500-ml vials)

Model:

NADA 65-110

Recall #: V-070-2010

Product: CSR Company, Inc. Penicillin-G (500-ml vials)

Model:

NADA 65-110

Recall #: V-070-2010

Product: AgriLabs Twin Pen (100-, 250-, 500-ml vials)

Model:

NADA 65-498

Recall #: V-071-2010

Product: AmTech Group, Inc. Pen BP-48 (100-, 250-, 500-ml vials)

Model:

NADA 65-498

Recall #: V-071-2010

Product: Aspen Penicillin G Benzathine and Penicillin G Procaine (100-, 250-, 500-ml vials)

Model:

NADA 65-498

Recall #: V-071-2010

Product: Butler Penject + B (100-, 250-ml vials)

Model:

NADA 65-498

Recall #: V-071-2010

Product: durvet Dura-Pen (100-, 250-ml vials)

Model:

NADA 65-498

Recall #: V-071-2010

Product: Phoenix Pharmaceutical, Inc. Dual-Cillin (100-, 250-ml vials)

Model:

NADA 65-498

Recall #: V-071-2010

Product: VEDCO Durapen (100-, 250-ml vials)

Model:

NADA 65-498

Recall #: V-071-2010

Product: AmTech Penicillin G Potassium (0.500 BIU and 1.0 BIU jars)

Model:

ANADA 200-347

Recall #: V-072-2010

Product: AmTech Griseofulvin Powder Microsize (15-gram pouches)

Model:

ANDA 200-391

Recall #: V-073-2010

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 53757

Status: Resolved

Manufacturer: TEVA Animal Health Inc

Sold By: Butler Animal Health Supply; Clipper Distributing Company, LLC; VEDCO, Inc.; Agri Laboratories, Ltd.; DURVET, INC.; CSR; Aspen Veterinary Resources, Ltd.

Manufactured In: United States

Units Affected: 4 products (116,282/100-ml vials, 93,342/250-ml. vials; and 91,199/500-ml. vials; 143,570/100-ml vials; 204,312/250-ml. vials; and 29,481/500-ml. vials; .5000 BIU - 134,554 jars; 1 BIU - 48,642 jars; 7,807/15-gram pouches)

Distributed To: Nationwide

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 if you have any of the affected products by checking labels for brand names including AmTech, Aspen, Butler, AgriLabs, durvet, Phoenix, VEDCO, novopharm, or CSR.

Check the specific product type and size: affected items include injectable Penicillin vials in 100-ml, 250-ml, and 500-ml sizes; Penicillin G Potassium in 0.5 or 1.0 billion unit jars; and Griseofulvin Powder in 15-gram pouches.

Immediately stop using the recalled medications on any animals.

Contact your veterinarian or pharmacist for guidance on the health of your animals and to arrange for alternative medications.

Return any unused product to the place of purchase for a full refund and contact TEVA Animal Health Inc. for further instructions.

For additional questions, contact the FDA Center for Veterinary Medicine (CVM) at 240-402-7002.

Affected Products

Product: AmTech Group Inc. Pen-G Max (100-, 250-, 500-ml vials)

Model:

NADA 65-110

Recall #: V-070-2010

Product: Aspen Penicillin G Procaine (100-, 250-, 500-ml vials)

Model:

NADA 65-110

Recall #: V-070-2010

Product: Butler Penject (100-, 250-ml vials)

Model:

NADA 65-110

Recall #: V-070-2010

Product: Phoenix Pharmaceutical, Inc. Pen-G (100-, 250-ml vials)

Model:

NADA 65-110

Recall #: V-070-2010

Product: VEDCO Aquacillin (100-, 250-, 500-ml vials)

Model:

NADA 65-110

Recall #: V-070-2010

Product: novopharm Penicillin G Procaine Injectable Suspension (250-, 500-ml vials)

Model:

NADA 65-110

Recall #: V-070-2010

Product: CSR Company, Inc. Penicillin-G (500-ml vials)

Model:

NADA 65-110

Recall #: V-070-2010

Product: AgriLabs Twin Pen (100-, 250-, 500-ml vials)

Model:

NADA 65-498

Recall #: V-071-2010

Product: AmTech Group, Inc. Pen BP-48 (100-, 250-, 500-ml vials)

Model:

NADA 65-498

Recall #: V-071-2010

Product: Aspen Penicillin G Benzathine and Penicillin G Procaine (100-, 250-, 500-ml vials)

Model:

NADA 65-498

Recall #: V-071-2010

Product: Butler Penject + B (100-, 250-ml vials)

Model:

NADA 65-498

Recall #: V-071-2010

Product: durvet Dura-Pen (100-, 250-ml vials)

Model:

NADA 65-498

Recall #: V-071-2010

Product: Phoenix Pharmaceutical, Inc. Dual-Cillin (100-, 250-ml vials)

Model:

NADA 65-498

Recall #: V-071-2010

Product: VEDCO Durapen (100-, 250-ml vials)

Model:

NADA 65-498

Recall #: V-071-2010

Product: AmTech Penicillin G Potassium (0.500 BIU and 1.0 BIU jars)

Model:

ANADA 200-347

Recall #: V-072-2010

Product: AmTech Griseofulvin Powder Microsize (15-gram pouches)

Model:

ANDA 200-391

Recall #: V-073-2010

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 53757

Status: Resolved

Manufacturer: TEVA Animal Health Inc

Sold By: Butler Animal Health Supply; Clipper Distributing Company, LLC; VEDCO, Inc.; Agri Laboratories, Ltd.; DURVET, INC.; CSR; Aspen Veterinary Resources, Ltd.

Manufactured In: United States

Distributed To: Nationwide