FDA-Drug2014-11-05Class II

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

West-Ward Pharmaceutical Corp.
Hazard

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

Sold states
GA
Affected count
5,596 HDPE bottles
Manufactured in
465 Industrial Way W, N/A, Eatontown, NJ, United States
Products
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

Official notice

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

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