Multi-event October 2015 FDA Recall Drug by Par Pharmaceutical Inc.

This Multi-event Class III drug recall was voluntarily initiated by Par Pharmaceutical Inc. on October 26, 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-0234-2016 TERMINATED D-0233-2016 TERMINATED

Recall Number: D-0234-2016

Reason for Recall
Failed Impurities/Degradation Specifications: Out of specification for impurities.
Initiated
10-26-2015
Reported
11-25-2015
Quantity
a) 387,100 Bottles; b) 63,572 Bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72476
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.
Par Pharmaceutical 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. Nationwide including Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-20-2017
Product Description About Product Description
Full technical description of the product.
Meclizine Hydrochloride Tablets USP, 25 mg Tablets, Packaged in a) 100 Ct Bottles (NDC: 49884-035-01) and b) 1000 Ct Bottles (NDC: 49884-035-10), Rx only. Par Pharmaceutical Companies, Inc., Spring Valley, NY 10977.

Batch or Lot Expiration Information

Lot# a)
Lot# : 25552101, Expiry: AUG 2016
Lot# : 25712701, Expiry: SEP 2016
Lot# : 25787902, Expiry: NOV 2016
Lot# : 26074601, Expiry: JAN 2017
Lot# : 26259801, Expiry: APR 2017
Lot# : 26220001, Expiry: MAR 2017
Lot# : 26579001, Expiry: JUN 2017
Lot# : 26731801, Expiry: NOV 2017. b)
Lot# : 24502301, Expiry: OCT 2015
Lot# : 24505901, Expiry: OCT 2015
Lot# : 25787901, Expiry: NOV 2016
Lot# : 26074701, Expiry: JAN 2017
Lot# : 26259701, Expiry: MAR 2017
Lot# : 26575801, Expiry: JUN 2017
Lot# : 26579002, Expiry: JUN 2017
Lot# : 26682801, Expiry: SEP 2017
Lot# : 26682901, Expiry: SEP 2017
Lot# : 26731702, Expiry: NOV 2017
Lot# : 25960301, Expiry: NOV 2017
Lot# : 26764801, Expiry: MAR 2018.

Recall Number: D-0233-2016

Reason for Recall
Failed Impurities/Degradation Specifications: Out of specification for impurities.
Initiated
10-26-2015
Reported
11-25-2015
Quantity
a) 162,385 Bottles; b) 6949 Bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72476
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.
Par Pharmaceutical 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. Nationwide including Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-20-2017
Product Description About Product Description
Full technical description of the product.
Meclizine Hydrochloride Tablets, USP, 12.5 mg Tablets, Packaged in a) 100 Ct Bottles (NDC: 49884-034-01) and b) 1000 Ct Bottles (NDC: 49884-034-10), Rx only. Par Pharmaceutical Companies, Inc., Spring Valley, NY 10977.

Batch or Lot Expiration Information

Lot# a)
Lot# : 24820001, Expiry: NOV 2015
Lot# : 25783601, Expiry: OCT 2016
Lot# : 25783801, Expiry: OCT 2016
Lot# : 26731201, Expiry: AUG 2017
Lot# : 26762002, Expiry: FEB 2018. b)
Lot# : 26683201, Expiry: AUG 2017
Lot# : 26762001, Expiry: FEB 2018.