D-0633-2018 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- April 25, 2018
- Initiation Date
- March 30, 2018
- Termination Date
- June 4, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2135 cartons
Product Description
Amantadine HCl Capsules, USP, 100 mg, 50 Capsules (5x10) Unite Dose, Rx Only, Manufactured for: AvKARE Inc. Pulaski, TN 38478 --- NDC 50268-069-15
Reason for Recall
Failed Dissolution Specifications
Distribution Pattern
Nationwide
Code Information
Lot: 16719 Exp. 07/2018