Recalls / Class III

Class IIID-0233-2016

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.

Affected lot / code info

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.

Why it was recalled

Failed Impurities/Degradation Specifications: Out of specification for impurities.

Recalling firm

Firm

Par Pharmaceutical Inc.

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

1 Ram Ridge Rd, N/A, Spring Valley, New York 10977-6714

Distribution

Quantity

a) 162,385 Bottles; b) 6949 Bottles

Distribution pattern

U.S. Nationwide including Puerto Rico

Timeline

Recall initiated

2015-10-26

FDA classified

2015-11-13

Posted by FDA

2015-11-25

Terminated

2017-04-20

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0233-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.