March 2013 FDA Recall Drug by Gsms
D-244-2013 - Presence of Foreign Substance

This Class II drug recall was voluntarily initiated by Gsms on March 11, 2013 for the product Drug. The FDA reported the reason for recall as presence of foreign substance. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-244-2013

Reason for Recall
Presence of Foreign Substance: Reports of gray smudges identified as minute stainless steel particulates were found in the recalled tablets by the manufacturer
Initiated
03-11-2013
Reported
04-17-2013
Quantity
6158 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64695
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.
Gsms
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.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-03-2013
Product Description About Product Description
Full technical description of the product.
LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS, USP, 20 mg/25 mg, 100 (NDC 60429-046-01) and 1,000 (NDC 60429-046-10) count bottles, Rx only, GSMS Inc., Camarillo, CA

Batch or Lot Expiration Information

Lot# Exp NDC
Lot# Date 60429-046-10 69393A1 09/2015 60429-046-1 0 69395A1 09/2015 60429-046-10 69495A1 10/2015 60429-046-10 69496A1 10/2015 60429-046-01 69497A1 02/2014 60429-046-10 69524A1 10/2015 60429-046-10 69524A2 10/2015 60429-046-10 69525A1 10/2015 60429-046-10 69525A2 10/2015