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Recall Observatory FDA recall evidence

Drug product

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).

D-0595-2024

July 02, 2024

Class III

Product summary

Firm
Zydus Pharmaceuticals (USA) Inc
Event
Event 94922
Status
Completed
Classification
Class III
Quantity
12720 vials
Official record key
drug-enforcement:D-0595-2024

Official wording

Reason: Cross contamination with other products

Code information: Lot #: L300220, Exp. 05/31/2025.

Distribution pattern: Nationwide in the USA and Puerto Rico

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Cross contamination with other products

Field note

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