Class II · Moderate risk Ongoing
Biotin for Injection
Reason Lack of Assurance of Sterility
Biotin 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
Biotin USP (Vitamin H) for prescription compounding, packaged in a) 500mg (NDC 58597-8142-1); b) 1g (NDC 58597-8142-2); c) 5g (NDC 58597-8142-3); d ) 25g (NDC 58597-8142-4), Rx only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
- Recalling firm
- American Pharmaceutical Ingredients LLC
- NDC code
- 58597-8142-1
- Origin
- MI, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0536-2018
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 Biotin recalls
See all
Class II · Moderate risk Ongoing
Biotin 5mg/mL
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Biotin Solution for Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Minoxidil/Biotin/Spironolactone 1.25/5/25mg capsules
Reason Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk Terminated
Minoxidil/Biotin 1.25mg/5mg Capsule
Reason Lack of Processing Controls (lack of assurance of conformity to specifications).
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