PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: November 5, 2014 Initiated: October 2, 2014 #D-0172-2015

Product Description

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.

Details

Units Affected
5,596 HDPE bottles
Distribution
GA
Location
Eatontown, NJ

Frequently Asked Questions

What product was recalled?
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. Recalled by West-Ward Pharmaceutical Corp.. Units affected: 5,596 HDPE bottles.
Why was this product recalled?
Subpotency: Out of Specification (OOS) result at the 36 month routine stability time point.
Which agency issued this recall?
This recall was issued by the FDA Drug on November 5, 2014. Severity: Moderate. Recall number: D-0172-2015.