FDA recall D-1111-2017

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: Labeled Error on Declared Strength; report of a 1000 ct bottle labeled as Phenobarbital 15 mg tablets actually contained 30 mg tablets

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-1111-2017