FDA recall D-839-2013

West-Ward Pharmaceutical Corp. · Class II · drug

Product

VersaPharm Incorporated, Ethambutol Hydrochloride Tablets, USP 400 mg 60 tablets, Rx Only, Mfd. for VersaPharm Incorporated Marietta, GA 30065-1509; Mfd. by: West-ward Pharmaceuticals Corp., Eatontown, NJ 07724 NDC 61748-014-06,

Reason for recall

Discoloration: Ethambutol HCl Tablets 400 mg is being recalled due to a Out of Specification result for description testing for a surface defect of ink.

Distribution

Key facts

Status: Terminated
Initiation date: 2013-06-04
Report date: 2013-08-14
Termination date: 2014-06-05
Voluntary/Mandated: Voluntary: Firm initiated
Location: Eatontown, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-839-2013