Reported Jan 31, 2024 · Completed
Mesalamine Delayed-Release Tablets, USP 1.2 g per tablet, Rx Only, 120 Tablets per bottle, Once Daily, Distributed by:…
Sun Pharmaceutical Industries Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: SUN PHARMACEUTICAL INDUSTRIES INC · 2 Independence Way · Princeton, NJ · 08540-6620
Is this the product you have?
- Mesalamine Delayed-Release Tablets, USP 1.2 g per tablet, Rx Only, 120 Tablets per bottle, Once Daily
- Distributed bySun Pharmaceutical Industries, Inc., Cranbury, NJ 08512
- Manufactured bySun Pharmaceutical Industries Limited Survey No. 259/15, Dadra-396 191 (U.T. of D & NH), INDIA, NDC 63304-175-13
- Lot codes and dates
Lot #s: DNE0875A Exp. 01/31/2025DNE0876ADNE0877ADNE1080ADNE1081A Exp. 02/28/2025DNE1147ADNE1148A Exp. 03/31/2025
- Amount recalled
- 10,690 bottles
This recall covers 11 products
The agency filed one notice per product. You are reading one of them; the other 10 are below.
Where it was sold
- Nationwide
Why it was recalled
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
This product could cause temporary or reversible health problems — stop using it.
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