FDA Drug recall D-0565-2022
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-c…
- FDA Drug
- Class II
- terminated
- Published 2022-02-23
On 2022-02-23 the FDA classified a Class II recall of 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-c… by Ani Pharmaceuticals, citing cGMP Deviations.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0565-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-02-15 |
| Published | 2022-02-23 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Ani Pharmaceuticals |
| Distribution | US |
Product
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
Reason
cGMP Deviations
Identifiers
| code_info | Lot #: a) 19B029A, Exp. Date 02/2022; 19D021A, Exp. Date 04/2022. b) 19A087B, 19A088B, 19A089B, 19A090B, Exp. Date 02/…Lot #: a) 19B029A, Exp. Date 02/2022; 19D021A, Exp. Date 04/2022. b) 19A087B, 19A088B, 19A089B, 19A090B, Exp. Date 02/2022; 19A086B, 19A091B, 19B019B, Exp. Date 02/2022. c) 19B020C, 19B021C, 19B027C, 19B028C, Exp. Date 02/2022, 19E056C, 19E057C, Exp. Date 05/2022; 19E059C, Exp. Date 06/2022 19G072C, Exp. Date 07/2022 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0565-2022%22
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