Recalls / Class III
Class IIID-0596-2024
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).
- Brand name
- Micafungin
- Generic name
- Micafungin
- Active ingredient
- Micafungin Sodium
- Route
- Intravenous
- NDCs
- 16714-301, 16714-164
- FDA application
- ANDA215241
- Affected lot / code info
- Lot #: L300217, Exp. 04/31/2025.
Why it was recalled
Cross contamination with other products
Recalling firm
- Firm
- Zydus Pharmaceuticals (USA) Inc
- Manufacturer
- Northstar Rx LLC.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 73 Route 31 N, N/A, Pennington, New Jersey 08534-3601
Distribution
- Quantity
- n/a
- Distribution pattern
- Nationwide in the USA and Puerto Rico
Timeline
- Recall initiated
- 2024-07-02
- FDA classified
- 2024-07-10
- Posted by FDA
- 2024-07-17
- Status
- Completed
Source: openFDA Drug Enforcement endpoint. Recall record D-0596-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.