January 2013 FDA Recall Drug by West-ward Pharmaceutical Corp.
D-164-2013 - Subpotent Drug

This Class III drug recall was voluntarily initiated by West-ward Pharmaceutical Corp. on January 7, 2013 for the product Drug. The FDA reported the reason for recall as subpotent drug. The product was distributed in OH and the recall is currently terminated.

Recall Number: D-164-2013

Reason for Recall
Subpotent Drug
Initiated
01-07-2013
Reported
02-20-2013
Quantity
1,185 Bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64108
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
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.
OH
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-16-2014
Product Description About Product Description
Full technical description of the product.
Glycopyrrolate Tablets, USP, 1 mg, Rx Only, 100 tablets per bottle, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ, 07724, NDC 0143-1250-01.

Batch or Lot Expiration Information

Lot# : 69001A