Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Labeling: Label Mixup; MESALAMINE CR, Capsule, 250 mg may be potentially mislabeled as ASPIRIN EC, Tablet, 325 mg, NDC 00904201360, Pedigree: AD52378_1, EXP: 5/17/2014.
MESALAMINE CR Capsule, 250 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 54092018981
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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