Drug product
Meclizine HCl Tablets, USP, 25 mg, 100 Tablets bottles, Rx Only, Mfd. for: Wilshire Pharmaceuticals, Inc., Atlanta, GA 30328, Product of India, NDC 52536-133-01
D-0259-2021
Product summary
- Event
- Event 87268
- Status
- Terminated
- Classification
- Class II
- Quantity
- 35928 bottles
- Official record key
drug-enforcement:D-0259-2021
Official wording
Reason: Failed Dissolution Specifications
Code information: Lot #: 18030329, 18030330, 18030331, Exp 03/2021.
Distribution pattern: FL, TX
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications