Drug recall D-0018-2015

Class III Terminated reported Oct 22, 2014

Product

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

Lots and codes

VASERETIC 10-25MG TAB 100CT Lot # 12J022P exp. 9/30/2014 VASERETIC 10-25MG TAB 100CT Lot # 13G047P exp. 07/31/2015

Recall details

Recalling firm
Valeant Pharmaceuticals North America LLC, Bridgewater, NJ
Quantity
205,853 bottles
Distribution
Nationwide
Type
Voluntary: Firm initiated
Recall initiated
May 21, 2014
Terminated
August 4, 2015

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