Reported Nov 30, 2016 · Terminated
Phenobarbital Tablets, USP 60mg 100=count bottles, Rx Only, Mfd. by: West-Ward Pharmaceutical Corp. Eatontown, NJ…
West-Ward Pharmaceuticals Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: West-Ward Pharmaceuticals Corp. · 401 Industrial Way West · Eatontown, NJ · 07724-2209
Is this the product you have?
- Phenobarbital Tablets, USP 60mg 100=count bottles, Rx Only, Mfd
- by
West-Ward Pharmaceutical Corp. EatontownNJ 07724NDC 0143-1455-01
- Lot codes and dates
Lot #: 71294AExp. 5/2017
- Amount recalled
- N/A
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Failed Dissolution Specifications: Phenobarbital Tablets have an out of specification for dissolution at the 12 month stability time point
This product could cause temporary or reversible health problems — stop using it.
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