Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Labeling: Label mix-up: Product secondary carton erroneously states 40mg instead of 30 mg, primary carton is label correctly.
Myorisan (isotretinoin capsules, USP), 40 mg, packaged in cartons of 30 Capsules containing 3 x 10 Prescription Packs, Rx Only, Distributed by: VersaPharm Inc. - An Akorn Company, Lake Forest, IL 60045, NDC 61748-304-13
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 Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
Reason Failed Dissolution Specifications
Reason Superpotent and Subpotent
Reason Superpotent and Subpotent
Reason Superpotent Drug: The 3-month stability result for assay was found to be above specification limit
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