Drug recall
Vaseretic (enalapril maleate/hydrochlorothiazide) 10/25 mg Tablets, NDC 0187-0146-01, 100 ct. bottles…
FDA recall event 68572 · Class III · Valeant Pharmaceuticals North America LLC
Key facts
| Event ID | 68572 |
|---|---|
| Recall numbers | D-0018-2015, D-0019-2015 |
| Recalling firm | Valeant Pharmaceuticals North America LLC |
| Product type | Drugs |
| Products | Vaseretic (enalapril maleate/hydrochlorothiazide) 10/25 mg Tablets, NDC 0187-0146-01, 100 ct. bottles manufactured at Valeant Pharmaceuticals International, Inc., Steinbach, MD R5G 1Z7 Canada, Vasotec (enalapril maleate) tablets, RX only, Manufactured by Valeant Pharmaceuticals International, Inc., Steinbach, MD R5G 1Z7 Canada 2.5 mg 90 ct - NDC 0187-0140-90 5 mg 30 ct - NDC 0187-0141-30 5… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of the package insert., Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of the package outset |
| Initiation date | May 21, 2014 |
| Report date | Oct 22, 2014 |
| Termination date | Aug 4, 2015 |
| City | Bridgewater |
| State | NJ |
| Country | United States |
| FEI number | 3010446985 |
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: