FDA Drug recall D-0568-2022
Pyrazinamide Tablets, USP 500 mg, 100-count bottles, Rx only, Manufactured by: ULTRAtab Laboratories, Inc
- FDA Drug
- Class II
- terminated
- Published 2022-02-23
On 2022-02-23 the FDA classified a Class II recall of Pyrazinamide Tablets, USP 500 mg, 100-count bottles, Rx only, Manufactured by: ULTRAtab Laboratories, Inc by Ani Pharmaceuticals, citing cGMP Deviations.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0568-2022 |
| 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
Pyrazinamide Tablets, USP 500 mg, 100-count bottles, Rx only, Manufactured by: ULTRAtab Laboratories, Inc. Highland, NY 12528, Distributed by Par Pharmaceuticals, Chestnut Ridge, NY 10977, NDC 67253-660-10.
Reason
cGMP Deviations
Identifiers
| code_info | Lot #: 19B064A, Exp. Date 03/2022 |
|---|
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-0568-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.