Drug product
Amantadine HCl Capsules, USP, 100 mg, 50 Capsules (5x10) Unite Dose, Rx Only, Manufactured for: AvKARE Inc. Pulaski, TN 38478 --- NDC 50268-069-15
D-0633-2018
Product summary
- Firm
- AVKARE Inc.
- Event
- Event 79680
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2135 cartons
- Official record key
drug-enforcement:D-0633-2018
Official wording
Reason: Failed Dissolution Specifications
Code information: Lot: 16719 Exp. 07/2018
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications