Drug product
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
D-1111-2017
Product summary
- Firm
- C. O. Truxton
- Event
- Event 77082
- Status
- Terminated
- Classification
- Class I
- Quantity
- unknown
- Official record key
drug-enforcement:D-1111-2017
Official wording
Reason: Labeling: Labeled Error on Declared Strength; report of a 1000 ct bottle labeled as Phenobarbital 15 mg tablets actually contained 30 mg tablets
Code information: Lot # 70952A; Exp. 11/17
Distribution pattern: Nationwide
Derived failure modes
-
Labeling or packaging
Labeling: Labeled Error