Drug recall
Amantadine HCl Capsules, USP, 100 mg, 50 Capsules (5x10) Unite Dose, Rx Only, Manufactured for: AvKARE Inc…
FDA recall event 79680 · Class II · AVKARE Inc.
Key facts
| Event ID | 79680 |
|---|---|
| Recall numbers | D-0633-2018 |
| Recalling firm | AVKARE Inc. |
| Product type | Drugs |
| Products | Amantadine HCl Capsules, USP, 100 mg, 50 Capsules (5x10) Unite Dose, Rx Only, Manufactured for: AvKARE Inc. Pulaski, TN 38478 --- NDC 50268-069-15 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Failed Dissolution Specifications |
| Initiation date | Mar 30, 2018 |
| Report date | Apr 25, 2018 |
| Termination date | Jun 4, 2020 |
| City | Pulaski |
| State | TN |
| Country | United States |
| FEI number | 3007255004 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: