Multi-event November 2015 FDA Recall Drug by Golden State Medical Supply Inc.

This Multi-event Class III drug recall was voluntarily initiated by Golden State Medical Supply Inc. on November 25, 2015 for the product Drug. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-0510-2016 TERMINATED D-0509-2016 TERMINATED

Recall Number: D-0510-2016

Reason for Recall
Failed Impurities/Degradation Specifications: Out of specification for impurities.
Initiated
11-25-2015
Reported
12-16-2015
Quantity
a) 737 Bottles; b) 3863 Bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72733
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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-07-2016
Product Description About Product Description
Full technical description of the product.
MECLIZINE HYDROCHLORIDE TABLETS, 25 mg, Packaged in a) 100 ct Bottles (NDC: 60429-205-01) and b) 1000 ct Bottles (NDC: 60429-205-10), Rx Only. Manufactured by: Par Pharmaceuticals Companies Inc., Spring Valley, NY 10977. Packaged by: GSMS Incorporated, Carmarillo, CA 93012.

Batch or Lot Expiration Information

Lot# a)
Lot# : GS005224, Expiry: Jul-16, Lot:#: GS007553, Expiry: Nov-17
Lot# : GS007858, Expiry: Nov-17. b)
Lot# : GS002674, Expiry: Jan-16
Lot# : GS003402, Expiry:May-16
Lot# : GS003582, Expiry: Jun-16
Lot# : GS004899, Expiry: Jun-16
Lot# : GS005908, Expiry: Jun-17
Lot# : GS006088, Expiry: Jun-17
Lot# : GS006254, Expiry: Sep-17
Lot# : GS007345, Expiry: Nov-17
Lot# : GS007664, Expiry: Nov-17
Lot# : GS007803, Expiry: Nov-17
Lot# : GS008091, Expiry: Nov-17.

Recall Number: D-0509-2016

Reason for Recall
Failed Impurities/Degradation Specifications: Out of specification for impurities.
Initiated
11-25-2015
Reported
12-16-2015
Quantity
1136 Bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72733
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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-07-2016
Product Description About Product Description
Full technical description of the product.
MECLIZINE HYDROCHLORIDE TABLETS, 12.5 mg, Packaged in 1000 ct Bottles, Rx Only. Manufactured by: Par Pharmaceuticals Companies Inc., Spring Valley, NY 10977. Packaged by: GSMS Incorporated, Carmarillo, CA 93012. NDC: 60429-204-10.

Batch or Lot Expiration Information

Lot# GS007205 Expiry: Aug-17
Lot# :GS007344, Expiry: Aug-17
Lot# : GS008089, Expiry: Feb-18
Lot# : GS008842, Expiry: Feb-18
Lot# : GS009055, Expiry: Feb-18
Lot# : GS009131; Expiry: Feb-18.