Class II · Moderate risk Ongoing
Tadalafil USP
Reason CGMP Deviations:Noted during FDA inspection
Tadalafil USP
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
Tadalafil USP (Monohydrate) for prescription compounding, packaged in a) 5g (NDC 58597-8538-2); b) 25g (NDC 58597-8538-4); c)100g (NDC 58597-8538-6); d) 500g (NDC 58597-8538-7); d) 1000g (NDC 58597-8538-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
- Recalling firm
- American Pharmaceutical Ingredients LLC
- NDC code
- 58597-8538-2
- Origin
- MI, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0524-2018
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 Tadalafil recalls
See all
Class II · Moderate risk Ongoing
Tadalafil USP
Reason CGMP Deviations:Noted during FDA inspection
Class II · Moderate risk Ongoing
Tadalafil USP
Reason CGMP Deviations:Noted during FDA inspection
Class II · Moderate risk Ongoing
Tadalafil Tablets
Reason cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Class II · Moderate risk Terminated
Tadalafil 5 mg tablets
Reason cGMP Deviations
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