FDA recall D-242-2013

Product

Ethambutol Hydrochloride Tablets, USP, 100 mg, 100-count tablets per bottle, Rx only, Mfd. for: Versapharm Incorporated, Marietta, GA; Mfd. by: West-Ward Pharmaceutical Corp., Eatontown, NJ 07724; NDC 61748-011-01.

Reason for recall

Subpotent Drug: Out Of Specification results for assay at the stability time-point of 24 months.

Distribution

Nationwide.

Key facts

Status

Terminated

Initiation date

2013-03-18

Report date

2013-04-10

Termination date

2013-12-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

Eatontown, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-242-2013