FDARecalled Mar 6, 2024 · #D-0350-2024
Mesalamine Extended-Release Capsules, USP 500mg, Rx Only, 120 Capsules per bottle, Manufactured by: Sun Pharmaceutical Industries Limited, Mohali, INDIA, Distributed by: Sun Pharmaceutical Industri...
Hazard
Class II — temporary health risk
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Failed Dissolution Specifications: Out of specification for dissolution. Classification: Class II Distribution: Nationwide in the U.S.
Product details
- 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.
- Type
- Drugs
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Model numbers
- —
- UPCs
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