Mycamine 100mg Intravenous Preparation Recalled for Sterility Assurance Deficiency
Sentara Infusion Services recalled Mycamine 100mg intravenous solution nationwide due to lack of sterility assurance. Patients should contact their healthcare provider.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for lack of sterility assurance in an intravenous antifungal medication. No illnesses or injuries have been reported, and the hazard is theoretical based on the deficiency in sterility assurance.
Plain-English summary
Sentara Infusion Services is recalling Mycamine 100mg in normal saline (NS), a 100mL intravenous antifungal medication prepared for patients nationwide. The medication was dispensed through their home infusion pharmacy services.
The recall was initiated due to lack of sterility assurance in the preparation process. This means the affected medication may not meet required sterility standards for intravenous use.
Patients who have received this medication should contact their healthcare provider or Sentara Infusion Services immediately for guidance. The affected product has a beyond-use date of December 25-29, 2022.
The recalled product
- Product
- MYCAMINE 100MG IN NS 100ML, antifungal, Rx Only, use with a homepump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
- Manufacturer
- Sentara Infusion Services
- Category
- Drug — Intravenous Medication
- Hazard
- Affected units
- 5
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)
- Beyond Use Date: December 25-29
- 2022
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 53 recalled by Sentara Infusion Services 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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