Drug product
Meclizine Hydrochloride Tablets, USP, 25 mg Tablets, Packaged in 10 x 10 Tablet Blister Pack Packages, Rx Only. Manufactured by: Par Pharmaceutical Companies, Inc., Spring Valley, NY 10977. Mylan. NDC: 51079-090-20.
D-0235-2016
Product summary
- Event
- Event 72595
- Status
- Terminated
- Classification
- Class III
- Quantity
- 4,609 Packages
- Official record key
drug-enforcement:D-0235-2016
Official wording
Reason: Failed Impurities/Degradation Specifications: Out of specification for impurities.
Code information: Lot #: 3060153, Expiry: 08/31/16
Distribution pattern: US Nationwide including Puerto Rico
Derived failure modes
-
Potency or specification failure
Out of specification