FDA Drug Class II — Moderate

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

Hazard

Labeling: Label Mixup; potentially mislabeled

Products

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, Distr
Brand
C. O. Truxton
UPC
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

Units Affected

unknown