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Meclizine Hydrochloride Tablets, USP, 12.5 mg Tablets, Packaged in a) 100 Ct Bottles (NDC: 49884-...

FDA Recall #D-0233-2016 — Class III — October 26, 2015

Recall #D-0233-2016 Date: October 26, 2015 Classification: Class III Status: Terminated

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.

Recalling Firm

Par Pharmaceutical Inc. — Spring Valley, NY

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

a) 162,385 Bottles; b) 6949 Bottles

Distribution

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.

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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