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.

FDA recall notice · announced November 25, 2015 · Par Pharmaceutical

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The product

Reason for recall

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

Notes

Distribution: U.S. Nationwide including Puerto Rico
Lot/code information: 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.
Quantity: a) 387,100 Bottles; b) 63,572 Bottles
Status: Terminated
Products in this recall event:
- 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 (D-0233-2016)
- 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 Va (D-0234-2016)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.