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.
Reported: March 6, 2024 Initiated: February 5, 2024 #D-0350-2024
Product Description
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.
Reason for Recall
Failed Dissolution Specifications: Out of specification for dissolution.
Details
- Recalling Firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Units Affected
- 54,960 bottles
- Distribution
- Nationwide in the U.S.
- Location
- Princeton, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by SUN PHARMACEUTICAL INDUSTRIES INC. Units affected: 54,960 bottles.
Why was this product recalled? ▼
Failed Dissolution Specifications: Out of specification for dissolution.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 6, 2024. Severity: Moderate. Recall number: D-0350-2024.
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