Medications & Supplements/Prescription Drugs

Par Pharmaceutical Inc.: BusPIRone Hydrochloride Tablets Recalled for Failed Impurity Specifications

Agency Publication Date: August 25, 2020

Summary

Par Pharmaceutical Inc. is recalling 11,347 bottles of BusPIRone Hydrochloride Tablets, USP 7.5 mg (a generic medication used to treat anxiety). The recall was initiated because the product failed to meet quality specifications for impurities and degradation during testing. This means the tablets may contain higher levels of breakdown products than allowed, which could impact the medication's safety or effectiveness.

Risk

The presence of impurities or degradation products exceeding specified limits can potentially lead to unexpected side effects or a reduction in the drug's therapeutic benefit for patients managing anxiety symptoms.

What You Should Do

Check your medication bottle to see if it is BusPIRone Hydrochloride Tablets, USP 7.5 mg with NDC# 49884-725-01.
Verify the lot number and expiration date on the label; this recall specifically affects Lot # 32091002 with an expiration date of May 2021.
Contact your healthcare provider or pharmacist immediately to discuss whether you should continue taking the medication or to obtain a replacement prescription.
Return any remaining tablets from the affected lot to your pharmacy for a refund.
Contact Par Pharmaceutical Inc. at their corporate offices or through your dispensing pharmacy for further instructions regarding this recall.
For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Healthcare 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: BusPIRone Hydrochloride Tablets, USP 7.5 mg (100-count bottle)

Model:

NDC# 49884-725-01

Recall #: D-1542-2020

Lot Numbers:

32091002 (exp. date May 2021)

Date Ranges: May 2021

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 86202

Status: Resolved

Manufacturer: Par Pharmaceutical Inc.

Sold By: major distributors

Manufactured In: United States

Units Affected: 11,347 bottles

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

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Check your medication bottle to see if it is BusPIRone Hydrochloride Tablets, USP 7.5 mg with NDC# 49884-725-01.

Verify the lot number and expiration date on the label; this recall specifically affects Lot # 32091002 with an expiration date of May 2021.

Contact your healthcare provider or pharmacist immediately to discuss whether you should continue taking the medication or to obtain a replacement prescription.

Return any remaining tablets from the affected lot to your pharmacy for a refund.

Contact Par Pharmaceutical Inc. at their corporate offices or through your dispensing pharmacy for further instructions regarding this recall.

For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.