Recalls / Class II
Class IID-0566-2022
Product
Alprazolam Tablets, USP 1.0 mg, packaged in a) 100-count bottles (NDC 67253-902-10), b) 500-count bottles (NDC 67253-902-50), and c) 1000-count bottles (NDC 67253-902-11), Rx only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977
- Affected lot / code info
- Lot #: a) 19B081A, Exp. Date 02/2022; 19E088A, 19E089A, Exp. Date 05/2022 b) 19A102B, Exp. Date 02/2022; 19D067B, 19D068B, Exp. Date 04/2022; 19D070C, Exp. Date 05/2022. c) 19F045C, 19F046C, Exp. Date 06/2022; 19B082C, 19B083C, Exp. Date 03/2022; 19D069C, 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
- 173,499 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-0566-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.