D-1045-2017 Class II Terminated
FDA drug recall D-1045-2017 was initiated by West-Ward Pharmaceuticals Corp. on Oct 3, 2016 and is designated Class II. Reason for recall: Failed Dissolution Specifications: Phenobarbital Tablets have an out of specification for dissolution at the 12 month stability time point The recall status is terminated (terminated Dec 26, 2017).
Recall details
- Product Type
- Drugs
- Report Date
- Nov 30, 2016
- Initiation Date
- Oct 3, 2016
- Termination Date
- Dec 26, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
Product description
Phenobarbital Tablets, USP 60mg 100=count bottles, Rx Only, Mfd. by: West-Ward Pharmaceutical Corp. Eatontown, NJ 07724, NDC 0143-1455-01
Reason for recall
Failed Dissolution Specifications: Phenobarbital Tablets have an out of specification for dissolution at the 12 month stability time point
Distribution pattern
Nationwide
Code information
Lot #: 71294A, Exp. 5/2017
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1045-2017
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026