FDA Drug recall D-1414-2014
Isoniazid Tablets, USP, 300 mg, Rx only, packaged in a) 100-count bottles, NDC 0143-1261-01, b) 1000-count bottles, NDC 0143-1261-10, Manuf…
- FDA Drug
- Class II
- terminated
- Published 2014-07-09
On 2014-07-09 the FDA classified a Class II recall of Isoniazid Tablets, USP, 300 mg, Rx only, packaged in a) 100-count bottles, NDC 0143-1261-01, b) 1000-count bottles, NDC 0143-1261-10, Manuf… by West Ward Pharmaceutical, citing failed Dissolution Specifications: Stability lots cannot support dissolution past the 36 month time point.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1414-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-05-20 |
| Published | 2014-07-09 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | West Ward Pharmaceutical |
| Distribution | US |
Product
Isoniazid Tablets, USP, 300 mg, Rx only, packaged in a) 100-count bottles, NDC 0143-1261-01, b) 1000-count bottles, NDC 0143-1261-10, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724; c) 30-count bottles, NDC 61748-013-30, d) 100-count bottles, NDC 61748-013-01, e) 1000-count bottles, NDC 61748-013-10, Mfd. for: VersaPharm Incorporated, Marietta, GA 30062; Mfd. by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724.
Reason
Failed Dissolution Specifications: Stability lots cannot support dissolution past the 36 month time point.
Identifiers
| code_info | Lot #: a) 67839A, 67839D, Exp 05/14; 67936A, Exp 02/15; b) 67839B, 67840C, Exp 05/14; 67936B, Exp 02/15; c) 67840A, Exp…Lot #: a) 67839A, 67839D, Exp 05/14; 67936A, Exp 02/15; b) 67839B, 67840C, Exp 05/14; 67936B, Exp 02/15; c) 67840A, Exp 05/14; d) 67840B, Exp 05/14; e) 67839C, Exp 05/14 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1414-2014%22
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