Drug product
Phenobarbital Tablets USP, 100 mg, a) 100 count bottles (NDC 0463-6152-01), b) 1000 count bottles (NDC 0163-6152-10), Rx Only, Manufactured by West-ward Pharmaceutical Corp. Eatontown, NJ 07724, Distributed by Truxton, Inc., Bellmawr, NJ 08031
D-1114-2017
Product summary
- Firm
- C. O. Truxton
- Event
- Event 77082
- Status
- Terminated
- Classification
- Class II
- Quantity
- unknown
- Official record key
drug-enforcement:D-1114-2017
Official wording
Reason: Labeling: Label Mixup; potentially mislabeled
Code information: a) Lot # 70989A; Exp. 02/18, Lot # 70973A; Exp. 01/18 b) Lot # 70973A; Exp. 01/18, Lot # H15A76; Exp. 02/18, Lot # 71346A; Exp. 12/19, Lot # 70989A; Exp. 02/18
Distribution pattern: Nationwide
Derived failure modes
-
Labeling or packaging
mislabeled