June 2013 FDA Recall Drug by West-ward Pharmaceutical Corp.
D-839-2013 - Discoloration

This Class II drug recall was voluntarily initiated by West-ward Pharmaceutical Corp. on June 4, 2013 for the product Drug. The FDA reported the reason for recall as discoloration. The product was distributed in GA and the recall is currently terminated.

Recall Number: D-839-2013

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.
Initiated
06-04-2013
Reported
08-14-2013
Quantity
118 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
65582
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
West-Ward Pharmaceutical Corp.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
GA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-05-2014
Product Description About Product Description
Full technical description of the 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,

Batch or Lot Expiration Information

Lot# Lot 69968B 03/14