RecallRadar

FDA Drug recall D-1114-2017

Phenobarbital Tablets USP, 100 mg, a) 100 count bottles (NDC 0463-6152-01), b) 1000 count bottles (NDC 0163-6152-10), Rx Only, Manufactured…

On 2017-08-30 the FDA classified a Class II recall of 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 C O Truxton, citing labeling: Label Mixup; potentially mislabeled.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-1114-2017
ClassificationClass II
Statusterminated
Initiated2017-04-20
Published2017-08-30
Last updated2026-09-13 11:51 UTC
CompanyC O Truxton
DistributionUS

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

Reason

Labeling: Label Mixup; potentially mislabeled

Identifiers

code_info
a) Lot # 70989A; Exp. 02/18, Lot # 70973A; Exp. 01/18 b) Lot # 70973A; Exp. 01/18, Lot # H15A76; Exp. 02/18, Lot #…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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1114-2017%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.