PlainRecalls
FDA Drug Low Class III Terminated

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

Reported: October 22, 2014 Initiated: May 21, 2014 #D-0018-2015

Product Description

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

Reason for Recall

Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of the package outset

Details

Units Affected
205,853 bottles
Distribution
Nationwide
Location
Bridgewater, NJ

Frequently Asked Questions

What product was recalled?
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. Recalled by Valeant Pharmaceuticals North America LLC. Units affected: 205,853 bottles.
Why was this product recalled?
Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of the package outset
Which agency issued this recall?
This recall was issued by the FDA Drug on October 22, 2014. Severity: Low. Recall number: D-0018-2015.