Reported Sep 2, 2020 · Terminated

BusPIRone Hydrochloride Tablets, USP 7.5 mg NDC# 49884-725-01

Par Pharmaceutical Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Par Pharmaceutical Inc. · 1 Ram Ridge Rd · Chestnut Ridge, NY · 10977-6714

Is this the product you have?

  • BusPIRone Hydrochloride Tablets, USP 7.5 mg NDC# 49884-725-01
Lot codes and dates
    • Lot # 32091002
    • exp. date May 2021
Amount recalled
11,347 bottles

Why it was recalled

Failed Impurity /Degradation Specifications

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Jun 7, 2021 · Data as of Sep 19, 5:07 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.