Class II · Moderate risk Ongoing
Claravis
Reason Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
Zenatane
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed dissolution specifications - low dissolution results at S3 stage.
What was recalled
Zenatane (isotretinoin) capsules, 20 mg, packaged in 30-count cartons (3 x 10 blister cards), Rx Only, Manufactured By:Cipla Limited Kurkumbh Village Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupally 500 090 India, NDC 55111-136-81
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- NDC code
- 55111-136-81
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0507-2017
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.
Other Isotretinoin recalls
See all
Class II · Moderate risk Ongoing
Amnesteem
Reason Failed Dissolution Specifications
Class II · Moderate risk Ongoing
Isotretinoin Capsules
Reason Superpotent and Subpotent
Class II · Moderate risk Ongoing
Isotretinoin Capsules
Reason Superpotent and Subpotent
Class II · Moderate risk Ongoing
Isotretinoin Capsules
Reason Superpotent Drug: The 3-month stability result for assay was found to be above specification limit
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