D-0633-2018 Class II Terminated
FDA drug recall D-0633-2018 was initiated by AVKARE Inc. on Mar 30, 2018 and is designated Class II. Reason for recall: Failed Dissolution Specifications The recall status is terminated (terminated Jun 4, 2020). Affected quantity: 2135 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- Apr 25, 2018
- Initiation Date
- Mar 30, 2018
- Termination Date
- Jun 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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0633-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026