Status
Ongoing
Drug Enforcement D-0596-2024
Cross contamination with other products
Classification
Class III
Report Date
July 17, 2024
Termination Date
—
Product Information
- Product description
- 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).
- Product quantity
- n/a
- Reason for recall
- Cross contamination with other products
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the USA and Puerto Rico
Location & Firm
- Recalling firm
- Zydus Pharmaceuticals (USA) Inc
- Address
-
73 Route 31 N, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0596-2024
- Event ID
- 94922
- Recall initiation date
- July 2, 2024
- Center classification date
- July 10, 2024
- Code info
- Lot #: L300217, Exp. 04/31/2025.
- More code info
- —