Recalls / Class II
Class IID-1045-2017
Product
Phenobarbital Tablets, USP 60mg 100=count bottles, Rx Only, Mfd. by: West-Ward Pharmaceutical Corp. Eatontown, NJ 07724, NDC 0143-1455-01
- Brand name
- Phenobarbital
- Generic name
- Phenobarbital
- Active ingredient
- Phenobarbital
- Route
- Oral
- NDCs
- 0143-1455, 0143-1495, 0143-1500, 0143-1458
- Affected lot / code info
- Lot #: 71294A, Exp. 5/2017
Why it was recalled
Failed Dissolution Specifications: Phenobarbital Tablets have an out of specification for dissolution at the 12 month stability time point
Recalling firm
- Firm
- West-Ward Pharmaceuticals Corp.
- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 401 Industrial Way West, N/A, Eatontown, New Jersey 07724-2209
Distribution
- Quantity
- N/A
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-10-03
- FDA classified
- 2016-11-18
- Posted by FDA
- 2016-11-30
- Terminated
- 2017-12-26
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1045-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.