Vaseretic Tablet
FDA Recall NDC 0187-0146
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Vaseretic (NDC 0187-0146). A significant event, classified as Class III, was initiated on May 21, 2014 by Bausch Health Us, Llc. The reported reason for this action was: "Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of the package outset"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Terminated
Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of the package outset
May 21, 2014
Oct 22, 2014
205,853 bottles
Recall Profile & Regulatory Data
Event ID
68572
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Valeant Pharmaceuticals North America LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Aug 04, 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
Batch or Lot Expiration Information
Lot# VASERETIC 10-25MG TAB 100CT
Lot# 12J022P exp. 9/30/2014 VASERETIC 10-25MG TAB 100CT
Lot# 13G047P exp. 07/31/2015
Affected Packages Involved in this Recall
0187-0146-01Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
