Class II · Moderate risk Ongoing
Claravis
Reason Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
Tretinoin USP for prescription compounding
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
What was recalled
Tretinoin USP for prescription compounding, packaged in a) 5g (NDC 58597-8033-2); 1b) 10g (NDC 58597-8033-3); c) 25g (NDC 58597-8033-4), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
- Recalling firm
- American Pharmaceutical Ingredients LLC
- NDC code
- 58597-8033-2
- Origin
- MI, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0530-2018
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 Tretinoin 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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