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.
Reported: January 31, 2024 Initiated: January 18, 2024 #D-0268-2024
Product Description
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 for Recall
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Details
- Recalling Firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Units Affected
- 10,690 bottles
- Distribution
- Nationwide in the USA
- Location
- Princeton, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by SUN PHARMACEUTICAL INDUSTRIES INC. Units affected: 10,690 bottles.
Why was this product recalled? ▼
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 31, 2024. Severity: Moderate. Recall number: D-0268-2024.
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