Recalls / Class III
Class IIID-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
- Brand name
- Vaseretic
- Generic name
- Enalapril Maleate And Hydrochlorothiazide
- Active ingredients
- Enalapril Maleate, Hydrochlorothiazide
- Route
- Oral
- NDC
- 0187-0146
- FDA application
- NDA019221
- Affected lot / code info
- VASERETIC 10-25MG TAB 100CT Lot # 12J022P exp. 9/30/2014 VASERETIC 10-25MG TAB 100CT Lot # 13G047P exp. 07/31/2015
Why it was recalled
Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of the package outset
Recalling firm
- Firm
- Valeant Pharmaceuticals North America LLC
- Manufacturer
- Bausch Health US, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 400 Somerset Corporate Blvd, N/A, Bridgewater, New Jersey 08807
Distribution
- Quantity
- 205,853 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-05-21
- FDA classified
- 2014-10-10
- Posted by FDA
- 2014-10-22
- Terminated
- 2015-08-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0018-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.