October 2014 FDA Recall Drug by West-ward Pharmaceutical Corp.
D-0172-2015 - Subpotency

This Class II drug recall was voluntarily initiated by West-ward Pharmaceutical Corp. on October 2, 2014 for the product Drug. The FDA reported the reason for recall as subpotency. The product was distributed in GA and the recall is currently terminated.

Recall Number: D-0172-2015

Reason for Recall
Subpotency: Out of Specification (OOS) result at the 36 month routine stability time point.
Initiated
10-02-2014
Reported
11-05-2014
Quantity
5,596 HDPE bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
69539
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.
08-03-2015
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

Lot# 68975A, #68976; Exp. 07/15