Matzim La Tablet, Extended Release
FDA Recall NDC 52544-694
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Matzim La (NDC 52544-694). A significant event, classified as Class II, was initiated on Jul 21, 2022 by Actavis Pharma, Inc.. The reported reason for this action was: "Failed Dissolution Specifications: below specification limits for dissolution."
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
Failed Dissolution Specifications: below specification limits for dissolution.
Jul 21, 2022
Aug 10, 2022
8022 bottles
Recall Profile & Regulatory Data
Event ID
90635
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Teva Pharmaceuticals USA Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA and Puerto Rico
Termination Date
Apr 18, 2023
Product Description
Matzim LA (Diltiazem Hydrochloride) Extended-Release Tablets, 180 mg, 30-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, USA; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, USA; NDC 52544-691-30.
Batch or Lot Expiration Information
Lot# Lot 1411593A, Exp 09/22
Affected Packages Involved in this Recall
52544-691-30Product
52544-691-19Product
52544-691-10Product
52544-692-30Product
52544-692-19Product
52544-692-10Product
52544-693-30Product
52544-693-19Product
52544-693-10Product
52544-694-30Product
52544-694-19Product
52544-694-10Product
52544-695-30Product
52544-695-19Product
52544-695-10Product
Class III Terminated
GMP Deviation: lot not intended for commercial distribution.
Sep 06, 2019
Oct 16, 2019
5,849 bottles
Recall Profile & Regulatory Data
Event ID
83730
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Teva Pharmaceuticals USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed to 42 wholesalers and 11 retailers who may have further distribute the product throughout the United States, including Hawaii and Puerto Rico.
Termination Date
May 19, 2020
Product Description
Matzim LA (Diltiazem Hydrochloride) Extended-Release Tablets, 240 mg, 30 count bottle, Rx only, Manufactured by: Actabis Laboratories FL, Inc., Fort Lauderdale, FL, Distributed by: Actavis Pharma, Inc., Parsippany, NJ NDC 52544-692-30
Batch or Lot Expiration Information
Lot# 1344864A, exp. date 10/2020
Affected Packages Involved in this Recall
52544-691-30Product
52544-691-19Product
52544-691-10Product
52544-692-30Product
52544-692-19Product
52544-692-10Product
52544-693-30Product
52544-693-19Product
52544-693-10Product
52544-694-30Product
52544-694-19Product
52544-694-10Product
52544-695-30Product
52544-695-19Product
52544-695-10Product
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.
