FDAFDA · Food and drugs·Recall number D-1542-2020
BusPIRone Hydrochloride Tablets, USP 7.5 mg NDC# 49884-725-01
Published September 2, 2020 · Recall initiated: August 10, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurity /Degradation Specifications
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Par Pharmaceutical Inc.
- Distributor
- Product was distributed to 9 major distributors throughout the United States.
- Lot
- Lot # 32091002, exp. date May 2021
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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