Drug product
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.
D-0233-2016
Product summary
- Event
- Event 72476
- Status
- Terminated
- Classification
- Class III
- Quantity
- a) 162,385 Bottles; b) 6949 Bottles
- Official record key
drug-enforcement:D-0233-2016
Official wording
Reason: Failed Impurities/Degradation Specifications: Out of specification for impurities.
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.
Distribution pattern: U.S. Nationwide including Puerto Rico
Derived failure modes
-
Potency or specification failure
Out of specification