Recalls / Class III
Class IIID-0234-2016
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.
- Affected lot / code info
- 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.
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) 387,100 Bottles; b) 63,572 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-0234-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.