Drug 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
D-0018-2015
Product summary
- Event
- Event 68572
- Status
- Terminated
- Classification
- Class III
- Quantity
- 205,853 bottles
- Official record key
drug-enforcement:D-0018-2015
Official wording
Reason: Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of the package outset
Code information: VASERETIC 10-25MG TAB 100CT Lot # 12J022P exp. 9/30/2014 VASERETIC 10-25MG TAB 100CT Lot # 13G047P exp. 07/31/2015
Distribution pattern: Nationwide
Derived failure modes
-
Labeling or packaging
Labeling: Incorrect or Missing