Recalls / Class II
Class IID-0567-2022
Product
Alprazolam Tablets, USP 2.0 mg, packaged in a) 100-count bottles (NDC 67253-903-10), b) 500-count bottles (NDC 67253-903-50), Rx only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977
- Affected lot / code info
- Lot #: a) 19C002A, Exp. Date 03/2022; 19E012A, 19E013A, Exp. Date 05/2022. b) 19C100B, Exp. Date 04/2022; 19E001B, 19E002B, Exp. Date 05/2022.
Why it was recalled
cGMP Deviations
Recalling firm
- Firm
- ANI Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 210 W Main St, N/A, Baudette, Minnesota 56623-2467
Distribution
- Quantity
- 70,788 bottles
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2022-02-15
- FDA classified
- 2022-02-17
- Posted by FDA
- 2022-02-23
- Terminated
- 2022-10-25
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0567-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.