Drug recall
Famciclovir tablets, 500 mg, packaged in 30-count unit dose cartons, Rx only, Manufactured for: AvKARE, Inc…
FDA recall event 76617 · Class II · AVKARE Inc.
Key facts
| Event ID | 76617 |
|---|---|
| Recall numbers | D-0610-2017 |
| Recalling firm | AVKARE Inc. |
| Product type | Drugs |
| Products | Famciclovir tablets, 500 mg, packaged in 30-count unit dose cartons, Rx only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, NDC 50268-307-13 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Failed impurities/ degradation specifications: Product was above specification for unknown impurities. |
| Initiation date | Feb 15, 2017 |
| Report date | Mar 29, 2017 |
| Termination date | Jun 1, 2022 |
| 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: