Valeant Pharmaceuticals North America LLC recalls Vasotec (enalapril maleate) tablets, RX only, Manufactured by Valeant Pharmaceuticals International, Inc., Steinbach, MD
Recalled October 22, 2014 · FDA recall D-0019-2015 · Valeant Pharmaceuticals North America
Hazard
Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of the package insert. · FDA Class III
Units
205,853 bottles
Sold at
Nationwide
Description
Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of the package insert.
Product
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 mg 90 ct - NDC 0187-0141-90 10 mg 30 ct - NDC 0187-0142-30 10 mg 90 ct - NDC 0187-0142-90 10 mg 1000 ct - NDC 0187-0142-10 20 mg 30 ct - NDC 0187-0143-30 20 mg 90 ct - NDC 0187-0143-90 20 mg 1000 ct - NDC 0187-0143-10 NDC #'s 64455-140, 64455-141, 64455-142 and 64455-143, 30 ct. bottles, 90 ct. bottles and 1000 ct. bottles
Manufacturer(s)
Valeant Pharmaceuticals North America LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →