August 2015 FDA Recall Drug by Golden State Medical Supply Inc.
D-1426-2015 - Presence of Foreign Substance

This Class III drug recall was voluntarily initiated by Golden State Medical Supply Inc. on August 11, 2015 for the product Drug. The FDA reported the reason for recall as presence of foreign substance. The product was distributed in U.S. Including: GA. and the recall is currently terminated.

Recall Number: D-1426-2015

Reason for Recall
Presence of Foreign Substance: Presence of hair.
Initiated
08-11-2015
Reported
09-16-2015
Quantity
1,165 Bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71921
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.
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Including: GA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-27-2015
Product Description About Product Description
Full technical description of the product.
METHOCARBAMOL TABLETS, USP 500 mg, 500 Count Bottles, Rx Only. Manufactured by AustarPharma LLC, Edison, NJ 08837, USA, Packaged by GSMS Incorporated, Camarillo, CA 93012, USA, NDC: 60429-118-05.

Batch or Lot Expiration Information

Lot# GS007849, Expiry: 02/2017