Recall: D-0862-2020

Class II - Potentially Harmful

Class IIClassification

2020-02-20Initiated

TerminatedStatus

Teva Pharmaceuticals USAFirm

Product

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.

Reason

Failed Dissolution Specifications: Low out of specification dissolution result observed during stability testing.

Distribution

Nationwide in the USA.

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