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
Recall Number: D-0019-2015
Firm: Valeant Pharmaceuticals North America LLC
Classification: Class III
Status: Terminated
Report Date: 20141022
Initiation Date: 20140521
Termination Date: 20150804
Reason for Recall
Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of the package insert.
Product Description
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