FDA recall D-0633-2018
AVKARE Inc. · Class II · 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
Reason for recall
Failed Dissolution Specifications
Distribution
Nationwide
Key facts
- Status
- Terminated
- Initiation date
- 2018-03-30
- Report date
- 2018-04-25
- Termination date
- 2020-06-04
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Pulaski, TN, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0633-2018