D-1111-2017 Class I Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- August 30, 2017
- Initiation Date
- April 20, 2017
- Termination Date
- September 11, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- unknown
Product Description
Phenobarbital Tablets USP, 15 mg, 1000 count bottles, Rx Only, Manufactured by West-ward Pharmaceutical Corp. Eatontown, NJ 07724, Distributed by Truxton, Inc., Bellmawr, NJ 08031, NDC 0463-6160-10
Reason for Recall
Labeling: Labeled Error on Declared Strength; report of a 1000 ct bottle labeled as Phenobarbital 15 mg tablets actually contained 30 mg tablets
Distribution Pattern
Nationwide
Code Information
Lot # 70952A; Exp. 11/17