Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Failed Dissolution Specifications
Mesalamine Delayed-Release Tablets, USP 1.2 gram (Once-Daily), 120 Tablets bottle, Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 38478 NDC 42291-564-12
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: Out-of-specification dissolution results were obtained during stability testing.
Reason Failed Dissolution Specifications: Low out of specification dissolution result observed during stability testing.
Reason Presence of Foreign Tablets/Capsules; 500 mg capsules were found in bottles labeled to contain 250 mg capsules
Tell us which medications you take. If the FDA recalls one, we email you - in plain English, with what to do. Free.