FDA recall D-1114-2017

C. O. Truxton · Class II · 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

Reason for recall

Labeling: Label Mixup; potentially mislabeled

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2017-04-20
Report date: 2017-08-30
Termination date: 2018-09-11
Voluntary/Mandated: Voluntary: Firm initiated
Location: Bellmawr, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1114-2017