D-0233-2016 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- November 25, 2015
- Initiation Date
- October 26, 2015
- Termination Date
- April 20, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- a) 162,385 Bottles; b) 6949 Bottles
Product Description
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.
Reason for Recall
Failed Impurities/Degradation Specifications: Out of specification for impurities.
Distribution Pattern
U.S. Nationwide including Puerto Rico
Code Information
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.