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.

Class I - Dangerous
💊 Drugs Recalled: October 26, 2015 Par Pharmaceutical Prescription Drugs Nationwide

What Should You Do?

  1. Check if you have this product:
    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.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. 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, 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.

Product Codes/Lot Numbers:

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.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0233-2016

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