Recalls / Class II
Class IID-0350-2024
Product
Mesalamine Extended-Release Capsules, USP 500mg, Rx Only, 120 Capsules per bottle, Manufactured by: Sun Pharmaceutical Industries Limited, Mohali, INDIA, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 63304-089-13.
- Brand name
- Mesalamine
- Generic name
- Mesalamine
- Active ingredient
- Mesalamine
- Route
- Oral
- NDC
- 63304-089
- FDA application
- ANDA214585
- Affected lot / code info
- Lot #s: MHD0606A, MHD0612A, Exp. 04/30/2024; MHD0613A, MHD0652A, MHD0657A, MHD0672A, MHD0673A, Exp. 05/31/2024; MHD0767A, MHD0768A, MHD0769A, MHD0785A, MHD0799A, MHD0800A, MHD0801A, Exp. 06/30/2024; MHD0827A, MHD0828A, MHD0875A, MHD0876A, MHD0898A, MHD0901A, Exp. 07/31/2024; MHD1081A, MHD1082A, MHD1087A Exp. 09/30/2024.
Why it was recalled
Failed Dissolution Specifications: Out of specification for dissolution.
Recalling firm
- Firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Manufacturer
- Sun Pharmaceutical Industries Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2 Independence Way, Princeton, New Jersey 08540-6620
Distribution
- Quantity
- 54,960 bottles
- Distribution pattern
- Nationwide in the U.S.
Timeline
- Recall initiated
- 2024-02-05
- FDA classified
- 2024-02-23
- Posted by FDA
- 2024-03-06
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0350-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.