FDA recall D-0172-2015

West-Ward Pharmaceutical Corp. · Class II · drug

Product

VERSAPHARM INCORPORATED Ethambutol Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx Only, Manufactured for VersaPharm Incorporated Marietta, GA 30065-1509 Manufactured by West-ward Pharmaceutical Corp. Eatontown, NJ 07724, NDC 61748-011-01

Reason for recall

Subpotency: Out of Specification (OOS) result at the 36 month routine stability time point.

Distribution

Key facts

Status: Terminated
Initiation date: 2014-10-02
Report date: 2014-11-05
Termination date: 2015-08-03
Voluntary/Mandated: Voluntary: Firm initiated
Location: Eatontown, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0172-2015