April 2014 FDA Recall Drug by Golden State Medical Supply Inc.
D-1357-2014 - Presence of Foreign Substance; some bottles may contain debris that was swept up during cleaning

This Class II drug recall was voluntarily initiated by Golden State Medical Supply Inc. on April 14, 2014 for the product Drug. The FDA reported the reason for recall as presence of foreign substance; some bottles may contain debris that was swept up during cleaning. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1357-2014

Reason for Recall
Presence of Foreign Substance; some bottles may contain debris that was swept up during cleaning
Initiated
04-14-2014
Reported
06-11-2014
Quantity
6,042 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
68009
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.
Golden State Medical Supply Inc.
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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-09-2014
Product Description About Product Description
Full technical description of the product.
LOSARTAN POTASSIUM Tablets, USP, 50 mg, 30 count bottles, Rx only, Manufactured by Arrow Pharm (Malta) Ltd., Bizebbugia, Malta, Packaged by GSMS, Inc. Camarillo, CA --- NDC 60429-317-30

Batch or Lot Expiration Information

Lot# Lot Number GS003057. Exp Date 03/2016.