Pegasus Laboratories, Inc.: Proin ER (phenylpropanolamine) Recalled for Microbial Contamination

Agency Publication Date: October 21, 2020

Summary

Pegasus Laboratories, Inc. has recalled approximately 5,436 bottles of Proin ER (phenylpropanolamine hydrochloride extended-release tablets) 145 mg, a medication used for dogs. The recall was initiated because the product tested outside of specifications for microbial limits, meaning it may contain bacteria or other microorganisms. These tablets were distributed in Missouri and come in 30-count and 90-count bottles. Owners should contact their veterinarian or pharmacist regarding this medication.

Risk

The product does not meet safety standards for microbial levels, which could introduce harmful bacteria to your pet. This contamination may lead to infection or other health complications for the animal consuming the tablets.

What You Should Do

Identify if you have the affected Proin ER 145 mg tablets by checking the packaging for Lot Number 200208.
Verify the National Drug Code (NDC) on the bottle: check for NDC 49427-347-44 on 90-tablet bottles or NDC 49427-347-57 on 30-tablet bottles.
If your bottle matches Lot 200208, stop administering the medication to your pet immediately.
Contact your veterinarian or pharmacist for guidance on alternative treatments and instructions on how to return the product.
Return any unused tablets to the pharmacy where they were purchased to receive a refund.
Contact Pegasus Laboratories, Inc. at their Pensacola, FL location for further information regarding this recall.
For additional questions, contact the FDA Center for Veterinary Medicine at 240-402-7002.

Your Remedy Options

Full Refund

Healthcare provider consultation and pharmacy refund

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

Affected Products

Product: Proin ER (phenylpropanolamine hydrochloride extended-release tablets) 145 mg (90 Tablets)

Model:

NDC 49427-347-44

Lot Numbers:

200208

Product: Proin ER (phenylpropanolamine hydrochloride extended-release tablets) 145 mg (30 Tablets)

Model:

NDC 49427-347-57

Lot Numbers:

200208

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 86635

Status: Resolved

Manufacturer: Pegasus Laboratories, Inc.

Manufactured In: United States

Units Affected: 5436 bottles

Distributed To: Missouri

Agency Last Updated: November 2, 2020

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 if you have the affected Proin ER 145 mg tablets by checking the packaging for Lot Number 200208.

Verify the National Drug Code (NDC) on the bottle: check for NDC 49427-347-44 on 90-tablet bottles or NDC 49427-347-57 on 30-tablet bottles.

If your bottle matches Lot 200208, stop administering the medication to your pet immediately.

Contact your veterinarian or pharmacist for guidance on alternative treatments and instructions on how to return the product.

Return any unused tablets to the pharmacy where they were purchased to receive a refund.

Contact Pegasus Laboratories, Inc. at their Pensacola, FL location for further information regarding this recall.

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