ANI Pharmaceuticals, Inc.: Drug Recall
Recall #D-0565-2022 · 02/15/2022
Class II: Risk
Recall Details
- Recall Number
- D-0565-2022
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- ANI Pharmaceuticals, Inc.
- Status
- Terminated
- Date Initiated
- 02/15/2022
- Location
- Baudette, MN, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 205,662 bottles
Reason for Recall
cGMP Deviations
Product Description
Alprazolam Tablets, USP 0.5 mg, packaged in a) 100-count bottles (NDC 67253-901-10), b) 500-count bottles (NDC 67253-901-50), and c) 1000-count bottles (NDC 67253-901-11), Rx only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977
Distribution Pattern
Nationwide within the United States
Other Recalls by ANI Pharmaceuticals, Inc.
- Class II: Risk 02/15/2022
- Class II: Risk 02/15/2022
- Class II: Risk 02/15/2022
- Class II: Risk 02/15/2022
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.