Drug product
Phenobarbital Tablets USP, 60 mg, 1000 count bottles, Rx Only, Manufactured by West-ward Pharmaceutical Corp. Eatontown, NJ 07724, Distributed by Truxton, Inc., Bellmawr, NJ 08031, NDC 0463-6151-10
D-1113-2017
Product summary
- Firm
- C. O. Truxton
- Event
- Event 77082
- Status
- Terminated
- Classification
- Class II
- Quantity
- unknown
- Official record key
drug-enforcement:D-1113-2017
Official wording
Reason: Labeling: Label Mixup; potentially mislabeled
Code information: Lot # 71416A; Exp. 05/20 Lot # 70881A; Exp. 07/17 Lot # H15A68; Exp. 01/18 Lot # 70980A; Exp. 02/18
Distribution pattern: Nationwide
Derived failure modes
-
Labeling or packaging
mislabeled