Recalls / Class II
Class IID-0564-2022
Product
Alprazolam Tablets, USP 0.25 mg, packaged in a) 100-count bottles (NDC 67253-900-10), b) 500-count bottles (NDC 67253-900-50), and c) 1000-count bottles (NDC 67253-900-11), Rx only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977
- Affected lot / code info
- Lot #: a) 19C003A, Exp. Date 03/2022; 19G002A, exp. date 07/2022; b) 19C004B, Exp. Date 03/2022; c) 19C048C, Exp. Date 03/2022
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
- 73,920 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-0564-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.