Bayer Healthcare Animal Health Inc: Spectam Injectable (spectinomycin) Recalled for Failed Stability Specifications

Agency Publication Date: November 13, 2015

Summary

Bayer Healthcare Animal Health Inc. is recalling 252 bottles of BAYER Spectam Injectable (spectinomycin) 100 mg/ml, an antibiotic used for veterinary purposes. This recall was initiated because the product failed stability testing, showing an out-of-specification result for a known impurity after six months. If you have this medication for animal use, contact your veterinarian or healthcare provider for guidance and return any unused product to the place of purchase for a refund.

Risk

The product contains a known impurity at levels higher than allowed by safety and quality standards, which may reduce the effectiveness of the medication or cause unexpected side effects in treated animals.

What You Should Do

Check your supply for BAYER Spectam Injectable (spectinomycin) 100 mg/ml in 500 ml glass bottles.
Identify if your product is part of the recall by looking for Lot number 634238 with an expiration date of 6/30/2016.
Contact your veterinarian or healthcare provider to discuss alternative treatments and to report any issues with the animal's health while using this lot.
Return any remaining bottles of the affected lot to the place of purchase or pharmacy to receive a refund.
Contact Bayer Healthcare Animal Health Inc at their Saint Joseph, Missouri location if you have specific questions regarding this product return.
For further information or to report adverse events, contact the FDA Center for Veterinary Medicine at 1-888-FDA-VETS.

Your Remedy Options

Full Refund

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

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

Affected Products

Product: BAYER Spectam Injectable (spectinomycin) 100 mg/ml (500 ml)

Model:

NDC 0859-2383-01

NADA 040-040

Lot Numbers:

634238 (Exp. 6/30/2016)

Date Ranges: Expiration Date 6/30/2016

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 70519

Status: Resolved

Manufacturer: Bayer Healthcare Animal Health Inc

Manufactured In: China, United States

Units Affected: 252 bottles

Distributed To: California, Kansas, Kentucky, Minnesota, Missouri

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 supply for BAYER Spectam Injectable (spectinomycin) 100 mg/ml in 500 ml glass bottles.

Identify if your product is part of the recall by looking for Lot number 634238 with an expiration date of 6/30/2016.

Contact your veterinarian or healthcare provider to discuss alternative treatments and to report any issues with the animal's health while using this lot.

Return any remaining bottles of the affected lot to the place of purchase or pharmacy to receive a refund.

Contact Bayer Healthcare Animal Health Inc at their Saint Joseph, Missouri location if you have specific questions regarding this product return.

For further information or to report adverse events, contact the FDA Center for Veterinary Medicine at 1-888-FDA-VETS.