PlainRecalls
FDA Drug Moderate Class II Terminated

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,

Reported: August 14, 2013 Initiated: June 4, 2013 #D-839-2013

Product Description

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.

Details

Units Affected
118 bottles
Distribution
GA
Location
Eatontown, NJ

Frequently Asked Questions

What product was recalled?
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,. Recalled by West-Ward Pharmaceutical Corp.. Units affected: 118 bottles.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Drug on August 14, 2013. Severity: Moderate. Recall number: D-839-2013.