Class III · Low risk
Micafungin for injection
Cross contamination with other products
Mycamine (micafungin) (Micafungin Sodium)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Labeling: Label Error on Declared Strength
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
What was recalled
Mycamine (micafungin) for Injection 100 mg/vial Single-Dose Vial Rx only Marketed by: Astellas Pharma US, Inc. Northbrook, IL 60062, NDC 0469-3211-10
Affected NDC
0469-3211-10
Compare with the code on your package — it is the most precise check available.
Drug: Micafungin
- Recalling firm
- Astellas Pharma US Inc
- NDC code
- 0469-3211-10
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0548-2018 · 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 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 sodium)
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Other recalls by Astellas Pharma US Inc
All 2018 recalls
Class I · High risk
Prograf (tacrolimus)
Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
Class I · High risk
Astagraf XL
Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
Class II · Moderate risk
Tarceva (erlotinib)
Failed Dissolution Specifications: The product did not meet the acceptance criteria for the dissolution test during the 24 month routine stability testing.
Class II · Moderate risk
AmBisome (amphotericin B)
Lack of Assurance of Sterility; Astellas Pharma US, Inc. is performing a voluntary recall on certain lots of AmBisome because the manufacturer has notified Astellas that during a routine simulation of the manufacturing of AmBisome, a bacterial contamination was detected in the media fills.
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