FDA Drug recall D-1045-2017
Phenobarbital Tablets, USP 60mg 100=count bottles, Rx Only, Mfd. by: West-Ward Pharmaceutical Corp
- FDA Drug
- Class II
- terminated
- Published 2016-11-30
On 2016-11-30 the FDA classified a Class II recall of Phenobarbital Tablets, USP 60mg 100=count bottles, Rx Only, Mfd. by: West-Ward Pharmaceutical Corp by West Ward Pharmaceuticals, citing failed Dissolution Specifications: Phenobarbital Tablets have an out of specification for dissolution at the 12 month stability time point.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1045-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-10-03 |
| Published | 2016-11-30 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | West Ward Pharmaceuticals |
| Distribution | US |
Product
Phenobarbital Tablets, USP 60mg 100=count bottles, Rx Only, Mfd. by: West-Ward Pharmaceutical Corp. Eatontown, NJ 07724, NDC 0143-1455-01
Reason
Failed Dissolution Specifications: Phenobarbital Tablets have an out of specification for dissolution at the 12 month stability time point
Identifiers
| ndc | 0143-1495-05 |
|---|---|
| ndc | 0143-1495-01 |
| ndc | 0143-1500-05 |
| ndc | 0143-1500-01 |
| ndc | 0143-1455-05 |
| ndc | 0143-1455-01 |
| ndc | 0143-1458-05 |
| ndc | 0143-1458-01 |
| code_info | Lot #: 71294A, Exp. 5/2017 |
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-1045-2017%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.