Drug recall
Enalapril Maleate Tablets USP, 5 mg, 100 Tablets (10X10) blister cards, 12 cartons in a shipper, Rx, Packaged…
FDA recall event 80389 · Class III · AMERICAN HEALTH PACKAGING
Key facts
| Event ID | 80389 |
|---|---|
| Recall numbers | D-0915-2018 |
| Recalling firm | AMERICAN HEALTH PACKAGING |
| Product type | Drugs |
| Products | Enalapril Maleate Tablets USP, 5 mg, 100 Tablets (10X10) blister cards, 12 cartons in a shipper, Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH --- NDC 68084-390-01 Carton… |
| Classification | Class III |
| Status | Terminated |
| Reason for recall | Failed Impurities/Degradation Specification; out-of-specification results for the Enalapril DKT degradant |
| Initiation date | Jun 25, 2018 |
| Report date | Jul 18, 2018 |
| Termination date | Apr 29, 2020 |
| City | Columbus |
| State | OH |
| Country | United States |
| FEI number | 3000209995 |
At a glance
- 1–9 Products in this recall
- 10–99 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: