Drug FDA Class III Completed Chemical
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).
Zydus Pharmaceuticals (USA) Inc Published Jul 17, 2024
Risk level
Class IIIUnlikely to cause harm, but violates labeling or manufacturing rules.
Severity score 35/100
What should you do?
- Check whether you have this product, using the lot codes, UPCs, and dates listed below.
- Do not eat, serve, or sell the affected product.
- Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
- Contact Zydus Pharmaceuticals (USA) Inc or your place of purchase with questions, and see the source record below for full details.
Reason for recall
Cross contamination with other products
Hazards
Cross contamination with other products · primary
Affected products (1)
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).
n/a
Code info: Lot #: L300217, Exp. 04/31/2025.
Affected areas
Nationwide
Timeline
- InitiatedJul 2, 2024
- PublishedJul 17, 2024
- Recall number
- D-0596-2024
- Agency
- U.S. Food and Drug Administration
- Country
- US
FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.