FDAFDA · Food and drugs·Recall number D-0268-2024
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.
Published January 31, 2024 · Recall initiated: January 18, 2024
Status when published: Completed — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- MESALAMINE
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Distributor
- Nationwide in the USA
- Lot
- Lot #s: DNE0875A Exp. 01/31/2025; DNE0876A, DNE0877A, DNE1080A, DNE1081A Exp. 02/28/2025; DNE1147A, DNE1148A Exp. 03/31/2025.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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