Recall: D-0268-2024

Class II - Potentially Harmful

Class IIClassification

2024-01-18Initiated

CompletedStatus

SUN PHARMACEUTICAL INDUSTRIES Firm

Product

Mesalamine Delayed-Release Tablets, USP 1.2 g per tablet, Rx Only, 120 Tablets per bottle, Once Daily, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited Survey No. 259/15, Dadra-396 191 (U.T. of D & NH), INDIA, NDC 63304-175-13.

Reason

CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.

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.