Mesalamine Tablet, Delayed Release
FDA Recall NDC 0591-2245
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 Mesalamine (NDC 0591-2245). A significant event, classified as Class II, was initiated on Oct 28, 2020 by Actavis Pharma, Inc.. The reported reason for this action was: "Failed Dissolution Specifications: Out-of-specification dissolution results were obtained during stability testing."
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: Out-of-specification dissolution results were obtained during stability testing.
Oct 28, 2020
Nov 18, 2020
133,829 bottles
Recall Profile & Regulatory Data
Event ID
86667
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Teva Pharmaceuticals USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the U.S. and PR
Termination Date
Aug 26, 2021
Product Description
Mesalamine Delayed-Release Tablets, USP 1.2 gram, 120 tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories, FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma Inc., Parsippany, NJ 07054, NDC 0591-2245-22.
Batch or Lot Expiration Information
Lot# s: 1342498A, Exp. 12/2020; 1342499A, Exp. 01/2021; 1354638A, Exp. 03/2021; 1354639A, 1358274A, 1358448A, 1364618A, 1369884A, Exp. 05/2021; 1366195A, 1369885A, 1373570A, Exp. 06/2021; 1373571A, Exp. 07/2021; 1388571A, Exp. 01/2022; 1395725A, 1396585A, 1397550A, 1399389A, Exp. 04/2022; 1403885A, 1403886A, Exp. 06/2022.
Affected Packages Involved in this Recall
0591-2245-22Product
Class II Terminated
Failed Dissolution Specifications: Low out of specification dissolution result observed during stability testing.
Feb 20, 2020
Mar 11, 2020
3,695 bottles
Recall Profile & Regulatory Data
Event ID
85017
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Teva Pharmaceuticals USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA.
Termination Date
Oct 06, 2020
Product Description
Mesalamine Delayed-Release Tablets, USP, 1.2 gram, 120-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054; NDC 0591-2245-22.
Batch or Lot Expiration Information
Lot# : 1342500A, Exp 10/2020
Affected Packages Involved in this Recall
0591-2245-22Product
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.
