Par Pharmaceutical Inc. recalls BusPIRone Hydrochloride Tablets, USP 7.5 mg NDC# 49884-725-01
- Recall date
- August 10, 2020
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-1542-2020
- FDA classification
- Class II
- Brand / firm
- Par Pharmaceutical Inc.
- Sold / distributed
- Product was distributed to 9 major distributors throughout the United States.
Why it was recalled
Failed Impurity /Degradation Specifications
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
BusPIRone Hydrochloride Tablets, USP 7.5 mg NDC# 49884-725-01
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