FDA recall D-1116-2017

C. O. Truxton · Class II · drug

Product

Phenobarbital Tablets USP, 15 mg, 1000 count bottles, Rx Only, Manufactured by West-ward Pharmaceutical Corp. Eatontown, NJ 07724, Distributed by Truxton, Inc., Bellmawr, NJ 08031, NDC 0463-6160-10

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-1116-2017