FDARecalled Jan 31, 2024 · #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 ...
Hazard
Class II — temporary health risk
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CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment. Classification: Class II Distribution: Nationwide in the USA
Product details
- 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.
- Type
- Drugs
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Model numbers
- —
- UPCs
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