Class III · Low risk
Micafungin for injection
Cross contamination with other products
MYCAMINE (micafungin sodium)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
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
MYCAMINE (micafungin sodium) 150MG, Packaged in 150ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
Drug: Micafungin
- Recalling firm
- Sentara Enterprises
- Origin
- VA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0644-2016 · 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 Micafungin recalls
See all
Class III · Low risk
Micafungin for injection
Cross contamination with other products
Class II · Moderate risk
Micafungin for Injection
Labeling; Incorrect or Missing Package Insert: The package insert provided with the product does not include all required sections approved for this product. This includes aspects of Adverse Reactions, Drug Interactions and Use in Specific Populations.
Class II · Moderate risk
Micafungin for Injection
Labeling; Incorrect or Missing Package Insert: The package insert provided with the product does not include all required sections approved for this product. This includes aspects of Adverse Reactions, Drug Interactions and Use in Specific Populations.
Class II · Moderate risk
Mycamine (micafungin)
Labeling: Label Error on Declared Strength
Other recalls by Sentara Enterprises
All 2015 recalls
Class II · Moderate risk
Dextrose-5% Lactated Ringers
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Class II · Moderate risk
Tobramycin 120MG
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Class II · Moderate risk
Gentamicin
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Class II · Moderate risk
Solu-Cortef
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
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