November 2012 FDA Recall Drug by West-ward Pharmaceutical Corp.
D-189-2013 - Discoloration

This Class II drug recall was voluntarily initiated by West-ward Pharmaceutical Corp. on November 30, 2012 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-189-2013

Reason for Recall
Discoloration: Ethambutol Tablets USP 400 mg have tablets cores that may be discolored.
Initiated
11-30-2012
Reported
03-13-2013
Quantity
18,825 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64105
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.
01-14-2014
Product Description About Product Description
Full technical description of the product.
VERSAPHARM Ethambutol Tablets, USP,400 mg, Rx Only a)60 tablets, NDC 61748-014-06, b)90 tablets, NDC 61748-014-09, c)100 tablets, NDC 61748-014-01, d)1000 tablets, NDC 61748-014-10, e) blister pack (10s) 61748-014-11 Manufactured for: VersaPharm Incorporated Marietta, GA 30062-2260, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724.

Batch or Lot Expiration Information

Lot# 68977A; 68977B; 68978B; 68978C; 68979A - exp JUL 2015 68977C; 68978A exp JUL 2013