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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Par Pharmaceutical Inc.
- Reason for Recall:
- Failed Impurities/Degradation Specifications: Out of specification for impurities.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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.
Product Codes/Lot Numbers:
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.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0234-2016
Related Recalls
BusPIRone Hydrochloride Tablets, USP 7.5 mg NDC# 49884-725-01
Par Pharmaceutical
Failed Impurity /Degradation Specifications
Failed Impurities/Degradation Specification: Presence of unknown impurity observed.
PrediniSONE Tablets, USP 5 mg, 48-count bottle, Rx only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977, NDC 0603-5337-31
Par Pharmaceutical
Labeling: Incorrect or Missing Exp Date - An incorrect expiration date has been identified on Prednisone Tablets USP 5 mg