Drug Enforcement D-0595-2024

Cross contamination with other products

Status

Ongoing

Classification

Class III

Report Date

July 17, 2024

Termination Date

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Product Information

Product description
Micafungin for injection, USP, 100 mg/vial, Single-Dose Vial, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Vadodara, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1725-01 (vial), NDC 70710-1725-06 (outer box).
Product quantity
12720 vials
Reason for recall
Cross contamination with other products
Recall initiation reason
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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
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Codes & Dates

Recall number
D-0595-2024
Event ID
94922
Recall initiation date
July 2, 2024
Center classification date
July 10, 2024
Code info
Lot #: L300220, Exp. 05/31/2025.
More code info
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