Key Takeaway

Phenobarbital Tablets, USP 60mg 100=count bottles, Rx Only, Mfd. by: West-Ward Pharmaceutical Corp. Eatontown, NJ 07724, NDC 0143-1455-01 by West-Ward Pharmaceuticals Corp. was recalled on October 3, 2016. The hazard: Failed Dissolution Specifications: Phenobarbital Tablets have an out of specification for dissolution at the 12 month stability time point

FDA Drug Class II Terminated

Phenobarbital Tablets, USP 60mg 100=count bottles, Rx Only, Mfd. by: West-Ward Pharmaceutical Corp. Eatontown, NJ 07724, NDC 0143-1455-01

Recalled: October 3, 2016 ~N/A units affected D-1045-2017

Description

Phenobarbital Tablets, USP 60mg 100=count bottles, Rx Only, Mfd. by: West-Ward Pharmaceutical Corp. Eatontown, NJ 07724, NDC 0143-1455-01

Hazard / Reason

Failed Dissolution Specifications: Phenobarbital Tablets have an out of specification for dissolution at the 12 month stability time point

Class II: Product that may cause temporary or medically reversible health consequences.

Class II indicates the product may cause temporary or medically reversible health effects. The probability of serious harm is considered remote.

Products Affected

Phenobarbital Tablets, USP 60mg 100=count bottles, Rx Only, Mfd. by: West-Ward Pharmaceutical Corp. Eatontown, NJ 07724, NDC 0143-1455-01

Drugs

Company Information

West-Ward Pharmaceuticals Corp.

Eatontown, NJ, United States

View all 6 recalls by West-Ward Pharmaceuticals Corp. →

Distribution

Nationwide

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Frequently Asked Questions

Is this recall still active?

Check the status badge at the top of this page. "Ongoing" means the recall is still active and you should follow the remedy instructions. "Completed" or "Terminated" means the recall process has concluded, though the safety issue remains relevant for any unrepaired products.

How do I check if my product is affected?

Compare the model number, lot code, serial number, or date range listed in the recall notice with the information on your product's label or packaging. For vehicles, check your VIN at NHTSA.gov/Recalls.

What remedy is available for this recall?

Check the remedy section above or contact the manufacturer directly for current remedy options.

Where can I find the original recall notice?

This recall was issued by FDA Drug. Visit the agency's official website for the original notice.

Data sourced from FDA Drug Enforcement. Recall information may not reflect the most current status. RecallDex is not affiliated with any US government agency. Contact the manufacturer or relevant agency for the latest information.