Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Failed Dissolution Specifications
ZENATANE (isotretinoin capsules USP) 20 mg, 30 capsules per prescription pack, Rx Only, Manufactured by: Cipla Limited, Kurkumbh Village Pune 4138012 India, Manufactured for: Dr. Reddy's Laboratories Limited Bachupally 500 090 India, NDC 55111-136-81
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 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
Tell us which medications you take. If the FDA recalls one, we email you - in plain English, with what to do. Free.