Sentara Recalls Mycamine Micafungin Sodium Due to Sterility Concerns
Sentara Enterprises is recalling 10 bags of Mycamine (micafungin sodium) 150mg because product sterility cannot be guaranteed.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text identifies this as an FDA Class II recall. Per the rubric, FDA Class II recalls are classified as Severe (Score 4), particularly when involving potential hospitalization or significant injury risks associated with sterility failures in injectable drugs.
Plain-English summary
Sentara Enterprises is recalling 10 bags of Mycamine (micafungin sodium) 150mg, packaged in 150ml Homepumps. The product is prescription-only and was distributed in Virginia and North Carolina. The recall involves all lots compounded between September 11, 2015, and September 17, 2015, with expiration dates of September 24, 2015, and September 27, 2015.
The recall was initiated because the assurance of sterility for the product cannot be guaranteed. This is an FDA Class II recall, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Consumers and healthcare providers should stop using the affected product and contact Sentara Enterprises or their healthcare provider for further instructions on disposal or replacement.
The recalled product
- Product
- MYCAMINE (micafungin sodium) 150MG, Packaged in 150ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
- Manufacturer
- Sentara Enterprises
- Category
- Drug — Antifungal
- Hazard
- Affected units
- 10
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)
- All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: 24-Sep-15
- 27-Sep-15
Distribution
Part of a larger recall action
This product is one of 34 recalled by Sentara Enterprises under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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