Medications & Supplements/Veterinary Medicines

Medisca Inc: Phenylbutazone Recalled Due to Extended Expiration and Lot Number Changes

Agency Publication Date: March 13, 2003

Summary

Medisca Inc. has recalled various sizes of Phenylbutazone, USP (NDC 38779-0497-7), a medication used in pharmacy compounding for veterinary purposes. Approximately 281 units, ranging from 100-gram bottles to 25-kilogram drums, are affected because the expiration dates were extended and lot numbers were changed without proper authorization or validation. Consumers and pharmacists should verify their inventory immediately, as this administrative and quality control error may result in the use of products beyond their original intended shelf life.

Risk

The unauthorized extension of expiration dates and alteration of lot numbers mean the stability and potency of the medication cannot be guaranteed, potentially leading to ineffective treatment or unpredictable reactions in animals.

What You Should Do

Check your inventory for Phenylbutazone, USP with NDC number 38779-0497-7 in any of the following sizes: 25 kg fiber drums, 5 kg plastic bottles, 1 kg plastic bottles, 500 gram plastic bottles, or 100 gram plastic bottles.
Verify if your product matches the affected quantities: 237 drums (25 kg), 11 bottles (5 kg), 6 bottles (1 kg), 12 bottles (500 g), or 15 bottles (100 g).
Immediately stop using the affected Phenylbutazone and quarantine any remaining stock to prevent further use in compounding.
Contact your veterinarian or healthcare provider to discuss alternative medications if your animal has been treated with products compounded from these specific lots.
Return any unused product to the place of purchase for a refund and contact Medisca Inc. at their Plattsburgh, New York facility for further instructions.
For additional information or to report concerns, contact the FDA Center for Veterinary Medicine at 240-402-7002.

Your Remedy Options

Full Refund

Pharmacy and consumer refund

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

Affected Products

Product: Phenylbutazone, USP (25 kg fiber drum)

Model:

NDC 38779-0497-7

Product: Phenylbutazone, USP (5 kg plastic bottle)

Model:

NDC 38779-0497-7

Product: Phenylbutazone, USP (1 kg plastic bottle)

Model:

NDC 38779-0497-7

Product: Phenylbutazone, USP (500 gram plastic bottle)

Model:

NDC 38779-0497-7

Product: Phenylbutazone, USP (100 gram plastic bottle)

Model:

NDC 38779-0497-7

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 25539

Status: Resolved

Manufacturer: Medisca Inc

Sold By: Pharmacy compounding customers

Manufactured In: United States

Units Affected: (1) 237 drums; (2) 11 bottles; (3) 6 bottles; (4) 12 bottles; (5) 15 bottles

Distributed To: California, Colorado, Connecticut, Florida, Iowa, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Texas, Utah, Virginia, Wyoming

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

Check your inventory for Phenylbutazone, USP with NDC number 38779-0497-7 in any of the following sizes: 25 kg fiber drums, 5 kg plastic bottles, 1 kg plastic bottles, 500 gram plastic bottles, or 100 gram plastic bottles.

Verify if your product matches the affected quantities: 237 drums (25 kg), 11 bottles (5 kg), 6 bottles (1 kg), 12 bottles (500 g), or 15 bottles (100 g).

Immediately stop using the affected Phenylbutazone and quarantine any remaining stock to prevent further use in compounding.

Contact your veterinarian or healthcare provider to discuss alternative medications if your animal has been treated with products compounded from these specific lots.

Return any unused product to the place of purchase for a refund and contact Medisca Inc. at their Plattsburgh, New York facility for further instructions.

For additional information or to report concerns, contact the FDA Center for Veterinary Medicine at 240-402-7002.

Affected Products

Product: Phenylbutazone, USP (25 kg fiber drum)

Model:

NDC 38779-0497-7

Product: Phenylbutazone, USP (5 kg plastic bottle)

Model:

NDC 38779-0497-7

Product: Phenylbutazone, USP (1 kg plastic bottle)

Model:

NDC 38779-0497-7

Product: Phenylbutazone, USP (500 gram plastic bottle)

Model:

NDC 38779-0497-7

Product: Phenylbutazone, USP (100 gram plastic bottle)

Model:

NDC 38779-0497-7

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 25539

Status: Resolved

Manufacturer: Medisca Inc

Sold By: Pharmacy compounding customers

Manufactured In: United States

Units Affected: (1) 237 drums; (2) 11 bottles; (3) 6 bottles; (4) 12 bottles; (5) 15 bottles