Drug recall
Acyclovir Tablets, USP, 400 mg, 50 Tablets (5 x 10) unit dose blisters [NDC 50268-061-11] per carton [NDC…
FDA recall event 79194 · Class II · Apace KY LLC
Key facts
| Event ID | 79194 |
|---|---|
| Recall numbers | D-0544-2018 |
| Recalling firm | Apace KY LLC |
| Product type | Drugs |
| Products | Acyclovir Tablets, USP, 400 mg, 50 Tablets (5 x 10) unit dose blisters [NDC 50268-061-11] per carton [NDC 50268-061-15], Rx Only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Presence of Foreign Tablet/Capsule; cartons labeled to contain Acyclovir tablets may contain Torsemide tablets in some of the blister cavities. |
| Initiation date | Feb 9, 2018 |
| Report date | Mar 7, 2018 |
| Termination date | Sep 10, 2019 |
| City | Fountain Run |
| State | KY |
| Country | United States |
| FEI number | 3005336862 |
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: