Recalls / Class II
Class IID-1542-2020
Product
BusPIRone Hydrochloride Tablets, USP 7.5 mg NDC# 49884-725-01
- Affected lot / code info
- Lot # 32091002, exp. date May 2021
Why it was recalled
Failed Impurity /Degradation Specifications
Recalling firm
- Firm
- Par Pharmaceutical Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Ram Ridge Rd, N/A, Chestnut Ridge, New York 10977-6714
Distribution
- Quantity
- 11,347 bottles
- Distribution pattern
- Product was distributed to 9 major distributors throughout the United States.
Timeline
- Recall initiated
- 2020-08-10
- FDA classified
- 2020-08-25
- Posted by FDA
- 2020-09-02
- Terminated
- 2021-06-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1542-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.