Class II · Moderate risk
Minoxidil 0.75%
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Minoxidil 0.5% W/Pres.
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
MINOXIDIL 0.5% W/PRES. (BENZYL ETOH 2%), 10ML Vials, MEDAUS PHARMACY
Drug: Minoxidil
- Recalling firm
- Medaus, Inc.
- Origin
- AL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1226-2016 · 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 Minoxidil recalls
See all
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).
Class II · Moderate risk
Formula 82M
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk
Formula 82F
Lack of Processing Controls (lack of assurance of conformity to specifications).
Other recalls by Medaus, Inc.
All 2016 recalls
Class II · Moderate risk
HCL 2mg/Ml
Lack of Assurance of Sterility
Class II · Moderate risk
Zinc So4 1mg/Ml
Lack of Assurance of Sterility
Class II · Moderate risk
Arginine 100mg/Ml
Lack of Assurance of Sterility
Class II · Moderate risk
Zinc So4 10mg/Ml
Lack of Assurance of Sterility
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