Recall: D-0069-2021

Class II - Potentially Harmful

Class IIClassification

2020-10-28Initiated

TerminatedStatus

Teva Pharmaceuticals USAFirm

Product

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.

Reason

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

Distribution

Nationwide in the U.S. and PR

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.