10 FDA recalls mention Mesalamine. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Mesalamine.
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.
Reason Presence of Foreign Tablets/Capsules; 500 mg capsules were found in bottles labeled to contain 250 mg capsules
Reason Presence of Particulate Matter: Stainless steel in a chemical reactor dissolved into the API solution and was detected in the finished product.
Reason Labeling: Label Mixup: MESALAMINE DR, Capsule, 400 mg may have potentially been mislabeled as the following drug: CHLOROPHYLLIN COPPER COMPLEX…
Reason Labeling: Label Mixup; MESALAMINE CR, Capsule, 500 mg may be potentially mislabeled as clomiPRAMINE HCl, Capsule, 50 mg, NDC 51672401205…
Reason Labeling: Label Mixup; MESALAMINE CR, Capsule, 250 mg may be potentially mislabeled as ASPIRIN EC, Tablet, 325 mg, NDC 00904201360, Pedigree…
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