Class II · Moderate risk Ongoing
Nandrolone Decanoate 200mg/mL
Reason Lack of Assurance of Sterility
Nandrolone Decanoate 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
Nandrolone Decanoate USP for prescription compounding, packaged in a) 25g (NDC 58597-0081-4); b) 100g (NDC 58597-0081-6); c) 500g (NDC 58597-0081-7); d) 1000g (NDC 58597-0081-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
- Recalling firm
- American Pharmaceutical Ingredients LLC
- NDC code
- 58597-0081-4
- Origin
- MI, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0512-2018
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 Nandrolone recalls
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Class III · Low risk Terminated
Nandrolone Decanoate
Reason Subpotent Drug
Class III · Low risk Terminated
Nandrolone Decanoate
Reason Subpotent Drug
Class III · Low risk Terminated
Nandrolone Decanoate
Reason Subpotent Drug
Class III · Low risk Terminated
Nandrolone Decanoate
Reason Subpotent Drug
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