Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Presence of Foreign Tablets/Capsules; 500 mg capsules were found in bottles labeled to contain 250 mg capsules
Pentasa (mesalamine) Controlled-Release Capsules, 250 mg, 240 count bottle, Rx only, Manufactured for Shire US Inc., Lexington, MA --- NDC 54092-189-81
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Failed Dissolution Specifications: Out of specification for dissolution.
Reason CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Reason Failed Dissolution Specifications
Reason Failed Dissolution Specifications: Out-of-specification dissolution results were obtained during stability testing.
Reason Failed Dissolution Specifications: Low out of specification dissolution result observed during stability testing.
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