Phenobarbital Tablets, USP 60mg 100=count bottles, Rx Only, Mfd. by: West-Ward Pharmaceutical Corp. Eatontown, NJ 07724, NDC 0143-1455-01
Reported: November 30, 2016 Initiated: October 3, 2016 #D-1045-2017
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
Details
- Recalling Firm
- West-Ward Pharmaceuticals Corp.
- Units Affected
- N/A
- Distribution
- Nationwide
- Location
- Eatontown, NJ
Frequently Asked Questions
What product was recalled? ▼
Phenobarbital Tablets, USP 60mg 100=count bottles, Rx Only, Mfd. by: West-Ward Pharmaceutical Corp. Eatontown, NJ 07724, NDC 0143-1455-01. Recalled by West-Ward Pharmaceuticals Corp.. Units affected: N/A.
Why was this product recalled? ▼
Failed Dissolution Specifications: Phenobarbital Tablets have an out of specification for dissolution at the 12 month stability time point
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 30, 2016. Severity: Moderate. Recall number: D-1045-2017.
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