Class II · Moderate risk
Biotin for Injection
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.
Cause type: Stability / shelf life
The product degraded or failed stability testing before its labeled expiry. Heat, moisture or time can break the drug down into degradants or reduce potency. All stability / shelf life recalls.
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
Affected NDCs
58597-8142-01
58597-8142-02
58597-8142-03
58597-8142-04
Compare with the code on your package — it is the most precise check available.
Drug: Biotin
- 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 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Biotin recalls
See all
Class II · Moderate risk
Biotin 5mg/mL
Lack of Assurance of Sterility
Class II · Moderate risk
Biotin Solution for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Minoxidil/Biotin/Spironolactone 1.25/5/25mg capsules
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk
Minoxidil/Biotin 1.25mg/5mg Capsule
Lack of Processing Controls (lack of assurance of conformity to specifications).
Other recalls by American Pharmaceutical Ingredients LLC
All 2018 recalls
Class II · Moderate risk
Sermorelin Acetate
Stability Data Does Not Support Expiry: Stability data from manufacturer does not support expiration dates listed.
Class II · Moderate risk
Oxytocin USP
Stability Data Does Not Support Expiry: Stability data from manufacturer does not support expiration dates listed.
Class II · Moderate risk
Fluticasone propionate USP
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Class II · Moderate risk
Cyanocobalamin USP
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.