Micafungin for Injection Recalled for Cross Contamination Risk
Zydus Pharmaceuticals recalls Micafungin for injection (Lot L300217) distributed nationwide due to potential cross contamination with other products. No illnesses have been reported.
What this means for you
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: FDA Class III classification indicates the lowest regulatory concern tier. No illnesses or injuries have been reported in the source text. The stated hazard of cross contamination is theoretical without confirmed harm, placing this within the Moderate category per the severity rubric.
Plain-English summary
Zydus Pharmaceuticals (USA) Inc is recalling Micafungin for injection, USP, 100 mg/vial, single-dose vials manufactured by Zydus Lifesciences Ltd. in Vadodara, India.
The recall has been initiated due to cross contamination with other products. This contamination may affect the quality and safety of the affected medication.
The affected product was distributed nationwide in the USA and Puerto Rico. The recall applies to Lot L300217 with expiration date 04/31/2025. Patients who have this medication should consult with their healthcare provider or pharmacist regarding the recall and for guidance on next steps or alternatives.
The recalled product
- Product
- Micafungin for injection, USP, 100 mg/vial, Single-Dose Vial, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Vadodara, India, NDC 16714-301-01 (vial), NDC 16714-301-10 (outer box).
- Manufacturer
- Zydus Pharmaceuticals (USA) Inc
- Category
- Drug — Injectable Antifungal
- Hazard
- cross-contamination
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)
- Lot #: L300217
- Exp. 04/31/2025.
Distribution
Distributed nationwide across the United States.
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