Drug product
Amantadine HCl, Capsules, UPS, 100 mg, 50 Capsules (5 x 10) unit dose, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478, www.avkare.com, NDC 50268-069-15.
D-0341-2026
Product summary
- Firm
- AvKARE
- Event
- Event 98449
- Status
- Ongoing
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-0341-2026
Official wording
Reason: Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution.
Code information: Lot # 49261, Exp: 04/30/27
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Potency or specification failure
Out of Specification