FDA Drug recall D-0125-2021
Imatinib Mesylate Tablets 400 mg, Rx Only, 30-count Bottle, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pharmace…
- FDA Drug
- Class II
- terminated
- Published 2020-12-16
On 2020-12-16 the FDA classified a Class II recall of Imatinib Mesylate Tablets 400 mg, Rx Only, 30-count Bottle, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pharmace… by Shilpa Medicare, citing CGMP Deviations.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0125-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-12-08 |
| Published | 2020-12-16 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Shilpa Medicare |
| Distribution | US |
Product
Imatinib Mesylate Tablets 400 mg, Rx Only, 30-count Bottle, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pharmaceuticals Inc., Manalapan, NJ 07726, NDC 72485-203-30.
Reason
CGMP Deviations
Identifiers
| ndc | 72485-203-30 |
|---|---|
| code_info | Lot #s: 7S10032A, 7S10034A, Exp. 02/28/2021 |
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-0125-2021%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.