FDA Drug recall D-0173-2021
Tizanidine Tablets, USP 4mg, Rx Only, 150 Tablets per Bottle, Manufactured by Alkem Laboratories Ltd, Mumbai - 400 013, INDIA, Distributed…
- FDA Drug
- Class II
- terminated
- Published 2020-12-09
On 2020-12-09 the FDA classified a Class II recall of Tizanidine Tablets, USP 4mg, Rx Only, 150 Tablets per Bottle, Manufactured by Alkem Laboratories Ltd, Mumbai - 400 013, INDIA, Distributed… by Ascend Laboratories, citing failed Dissolution Specifications; Out of Specification (low) results were obtained.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0173-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-11-24 |
| Published | 2020-12-09 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Ascend Laboratories |
| Distribution | MI |
Product
Tizanidine Tablets, USP 4mg, Rx Only, 150 Tablets per Bottle, Manufactured by Alkem Laboratories Ltd, Mumbai - 400 013, INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054, NDC: 67877-614-15.
Reason
Failed Dissolution Specifications; Out of Specification (low) results were obtained.
Identifiers
| ndc | 67877-613-15 |
|---|---|
| ndc | 67877-613-05 |
| ndc | 67877-614-15 |
| ndc | 67877-614-05 |
| code_info | Lot #19143017, Exp. 05/31/2021 |
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-0173-2021%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.