FDA recall D-0018-2015

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

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2014-05-21

Report date

2014-10-22

Termination date

2015-08-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Bridgewater, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0018-2015