Recall Enforment Report D-1302-2022

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Teva Pharmaceuticals USA Inc, originally initiated on 07-21-2022 for the product 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. The product was recalled due to failed dissolution specifications: below specification limits for dissolution.. The product was distributed nationwide and the recall is currently terminated.

Recall Enforcement Reports

Recall Number	Recall Initiation Date	Report Date	Recall Classification	Quantity	Product Description	Recall Reason	Status
D-1302-2022	07-21-2022	08-10-2022	Class II	8022 bottles	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.	Failed Dissolution Specifications: below specification limits for dissolution.	Terminated
D-1303-2022	07-21-2022	08-10-2022	Class II	5677 bottles	Matzim LA (Diltiazem Hydrochloride) Extended-Release Tablets, 240 mg, 30-count bottles, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL USA 33314, USA, Distributed by: Actavis Pharma Inc., Parsippany, NJ 07054 USA; NDC 58544-692-30.	Failed Dissolution Specifications: below specification limits for dissolution.	Terminated

Recalled Products

NDC	Proprietary Name	Non-Proprietary Name	Dosage Form	Route Name	Company Name	Product Type
52544-691	Matzim La	Diltiazem Hydrochloride	Tablet, Extended Release	Oral	Actavis Pharma, Inc.	Human Prescription Drug
52544-692	Matzim La	Diltiazem Hydrochloride	Tablet, Extended Release	Oral	Actavis Pharma, Inc.	Human Prescription Drug
52544-693	Matzim La	Diltiazem Hydrochloride	Tablet, Extended Release	Oral	Actavis Pharma, Inc.	Human Prescription Drug
52544-694	Matzim La	Diltiazem Hydrochloride	Tablet, Extended Release	Oral	Actavis Pharma, Inc.	Human Prescription Drug
52544-695	Matzim La	Diltiazem Hydrochloride	Tablet, Extended Release	Oral	Actavis Pharma, Inc.	Human Prescription Drug

Field Name	Field Value
Event ID	90635 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-1302-2022 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide in the USA and Puerto Rico What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
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.
Reason For Recall	Failed Dissolution Specifications: below specification limits for dissolution. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	8022 bottles Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	08-10-2022
Recall Initiation Date	07-21-2022 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	04-18-2023 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Teva Pharmaceuticals USA Inc
Code Info	Lot 1411593A, Exp 09/22 Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages	52544-691-10; 52544-691-19; 52544-691-30; 52544-692-10; 52544-692-19; 52544-692-30; 52544-693-10; 52544-693-19; 52544-693-30; 52544-694-10; 52544-694-19; 52544-694-30; 52544-695-10; 52544-695-19; 52544-695-30
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Field Name	Field Value
Event ID	90635 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-1303-2022 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide in the USA and Puerto Rico What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description	Matzim LA (Diltiazem Hydrochloride) Extended-Release Tablets, 240 mg, 30-count bottles, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL USA 33314, USA, Distributed by: Actavis Pharma Inc., Parsippany, NJ 07054 USA; NDC 58544-692-30.
Reason For Recall	Failed Dissolution Specifications: below specification limits for dissolution. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	5677 bottles Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	08-10-2022
Recall Initiation Date	07-21-2022 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	04-18-2023 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Teva Pharmaceuticals USA Inc
Code Info	Lot 1411596A, Exp 09/22 Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.