Teva Pharmaceuticals USA: 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:

Is my product affected?

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.

• Brand MESALAMINE

Check against the official notice below — it lists the full affected range.

What happened

Teva Pharmaceuticals USA is recalling Mesalamine Delayed-Release Tablets, USP 1.2 gram, 120 tablets per bottle, manufactured by Actavis Laboratories, FL, Inc. The recall affects approximately 133,829 bottles distributed nationwide in the U.S. and Puerto Rico. The recall was initiated because stability testing revealed that the tablets failed to meet dissolution specifications, meaning the medication may not dissolve properly in the body as intended.

The affected lots include multiple lot numbers with expiration dates ranging from December 2020 through June 2022. These specific lot numbers are: 1342498A, 1342499A, 1354638A, 1354639A, 1358274A, 1358448A, 1364618A, 1369884A, 1366195A, 1369885A, 1373570A, 1373571A, 1388571A, 1395725A, 1396585A, 1397550A, 1399389A, 1403885A, and 1403886A. The source document does not specify what affected consumers should do regarding this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Failed Dissolution Specifications: Out-of-specification dissolution results were obtained during stability testing.

Details from the source

Reason for recall: Failed Dissolution Specifications: Out-of-specification dissolution results were obtained during stability testing. Distribution: Nationwide in the U.S. and PR Quantity: 133,829 bottles Lot/code info: 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.

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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