Cartia Capsule, Extended Release
FDA Recall NDC 62037-600
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 Cartia (NDC 62037-600). A significant event, classified as Class II, was initiated on Oct 27, 2021 by Actavis Pharma, Inc.. The reported reason for this action was: "Labelling: Incorrect Exp. Date"
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 II Terminated
Labelling: Incorrect Exp. Date
Oct 27, 2021
Nov 24, 2021
32316 bottles
Recall Profile & Regulatory Data
Event ID
88936
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Teva Pharmaceuticals USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed Nationwide in the USA
Termination Date
Dec 21, 2022
Product Description
Cartia XT (Diltiazem Hydrochloride Extended-Release Capsules, USP) 120 mg, Rx Only, 90 capsules, labelled as (a) Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054; (b) Manufactured By: Actavis Laboratories FL. Inc, Fort Lauderdale FL. 33314 USA, Distributed by Avista Pharma Inc. Parsippany, NJ 07054 USA. NDC 62037-597-90
Batch or Lot Expiration Information
Lot# 100023805, Exp. Date 05/2023
Affected Packages Involved in this Recall
62037-597-90Product
62037-597-05Product
62037-598-90Product
62037-598-05Product
62037-599-90Product
62037-599-05Product
62037-600-90Product
62037-600-05Product
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.
