Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0548-2018·Announced 2018-02-14

Astellas Recalls Mycamine Injection Vials Due to Labeling Error

Astellas Pharma US Inc is recalling 63,600 vials of Mycamine (micafungin sodium) for Injection due to a label error on the declared strength.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error on declared strength, which fits the rubric criteria for minor labeling errors or low-risk contamination without reported serious injury.

Plain-English summary

Astellas Pharma US Inc is voluntarily recalling 63,600 vials of Mycamine (micafungin sodium) for Injection, 100 mg/vial. The recall is being conducted because of a labeling error regarding the declared strength of the medication. The affected product is a single-dose vial intended for intravenous use and is distributed nationwide.

The recall involves specific lots of the product: Lot F1700164 with an expiration date of 02/20 and Lot A000000220 with an expiration date of 06/20. The product is marketed by Astellas Pharma US, Inc. in Northbrook, IL, under NDC 0469-3211-10.

Healthcare providers and patients should check their inventory and medication records for these specific lot numbers and expiration dates. If the product is found, it should be held for return or disposal according to the recalling firm's instructions. This recall is classified as Class II by the FDA, indicating that use of the product could temporarily or medically reversibly affect health.

The recalled product

Product: MYCAMINE (MICAFUNGIN SODIUM)
Brand: MYCAMINE
Manufacturer: Astellas Pharma US Inc
Category: Drug — Antifungal Injection
Hazard: mis-labeling
Affected units: 63,600

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

Lots: F1700164 Exp. 02/20
A000000220 Exp. 06/20

Distribution

Distributed nationwide across the United States.

Same manufacturer · Astellas Pharma US Inc

See all →

Critical
Prograf Tacrolimus Capsules Recall: Empty Capsules in Bottles
FDA (Drugs) · 2025-02-05
Severe
FDA Class I Recall: Astagraf XL Immunosuppressant Capsules May Be Empty
FDA (Drugs) · 2025-02-05
Moderate
Astellas Recalls Tarceva Tablets Due to Failed Dissolution Specifications
FDA (Drugs) · 2014-10-15
Severe
Astellas Recalls AmBisome Injection Lots Due to Sterility Concerns
FDA (Drugs) · 2013-07-31

Same hazard · mis labeling