Class II · Moderate risk Ongoing
Claravis
Reason Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
Absorica
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Incorrect/Undeclared Excipients: Product contains undeclared FD&C Yellow No. 5 in the capsule shell.
What was recalled
Absorica (isotretinoin) Capsules, 25 mg, Packaged in 3 x 10 Count Blister Cards/Box, Rx Only. Manufactured for: RANBAXY LABORATORIES, INC Jacksonville, FL 32257 USA. NDC: 10631-133-31.
- Recalling firm
- Ranbaxy Inc.
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1288-2015
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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