FDA Drug recall D-0069-2021
Mesalamine Delayed-Release Tablets, USP 1.2 gram, 120 tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories, FL, Inc., Fort La…
- FDA Drug
- Class II
- terminated
- Published 2020-11-18
On 2020-11-18 the FDA classified a Class II recall of Mesalamine Delayed-Release Tablets, USP 1.2 gram, 120 tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories, FL, Inc., Fort La… by Teva Pharmaceuticals Usa, citing failed Dissolution Specifications: Out-of-specification dissolution results were obtained during stability testing.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0069-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-10-28 |
| Published | 2020-11-18 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Teva Pharmaceuticals Usa |
| Distribution | US |
Product
Mesalamine Delayed-Release Tablets, USP 1.2 gram, 120 tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories, FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma Inc., Parsippany, NJ 07054, NDC 0591-2245-22.
Reason
Failed Dissolution Specifications: Out-of-specification dissolution results were obtained during stability testing.
Identifiers
| ndc | 0591-2245-22 |
|---|---|
| code_info | Lot #s: 1342498A, Exp. 12/2020; 1342499A, Exp. 01/2021; 1354638A, Exp. 03/2021; 1354639A, 1358274A, 1358448A, 1364618A,…Lot #s: 1342498A, Exp. 12/2020; 1342499A, Exp. 01/2021; 1354638A, Exp. 03/2021; 1354639A, 1358274A, 1358448A, 1364618A, 1369884A, Exp. 05/2021; 1366195A, 1369885A, 1373570A, Exp. 06/2021; 1373571A, Exp. 07/2021; 1388571A, Exp. 01/2022; 1395725A, 1396585A, 1397550A, 1399389A, Exp. 04/2022; 1403885A, 1403886A, Exp. 06/2022. |
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-0069-2021%22
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