Trandolapril And Verapamil Hydrochloride Tablet, Film Coated, Extended Release
FDA Recall NDC 68462-296
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 Trandolapril And Verapamil Hydrochloride (NDC 68462-296). A significant event, classified as Class III, was initiated on Aug 14, 2023 by Glenmark Pharmaceuticals Inc., Usa. The reported reason for this action was: "Subpotent: Out of Specification for Assay Test at the 3-month time point."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class III Ongoing
Subpotent: Out of Specification for Assay Test at the 3-month time point.
Aug 14, 2023
Aug 30, 2023
1,200 bottles
Recall Profile & Regulatory Data
Event ID
92859
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
Glenmark Pharmaceuticals Inc., USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
nationwide in the U.S.
Product Description
Trandolapril and Verapamil Hydrochloride Extended-Release Tablets 2 mg / 180 mg, 100-count Bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale -Bardez, Goa 403513, India, Manufactured for Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-295-01
Batch or Lot Expiration Information
Batch# 19224744
Affected Packages Involved in this Recall
68462-329-01Product
68462-329-10Product
68462-295-01Product
68462-295-10Product
68462-295-90Product
68462-296-01Product
68462-296-10Product
68462-296-90Product
68462-294-01Product
68462-294-10Product
68462-294-90Product
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.
