Why it was recalled
Failed Impurities/Degradation Specifications: Out of specification for impurities.
Product 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.
Lot numbers, UPCs & expiration codes
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.
Where it was sold
U.S. Nationwide including Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0233-2016
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Oct 26, 2015
- FDA report date
- Nov 25, 2015
- Quantity
- a) 162,385 Bottles; b) 6949 Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Par Pharmaceutical Inc.
Original FDA data
Every field from FDA enforcement report D-0233-2016, exactly as published.
Show all FDA fields
- City
- Spring Valley
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 72476
- Address
- 1 Ram Ridge Rd
- Code information
- 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.
- Postal code
- 10977-6714
- Report date
- Nov 25, 2015
- Product type
- Drugs
- Recall number
- D-0233-2016
- Classification
- Class III
- Recalling firm
- Par Pharmaceutical Inc.
- Product quantity
- a) 162,385 Bottles; b) 6949 Bottles
- Termination date
- Apr 20, 2017
- Reason for recall
- Failed Impurities/Degradation Specifications: Out of specification for impurities.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product 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.
- Distribution pattern
- U.S. Nationwide including Puerto Rico
- Recall initiation date
- Oct 26, 2015
- Initial firm notification
- Letter
- Center classification date
- Nov 13, 2015