D-0596-2024Class III

Zydus Pharmaceuticals (USA) Inc

Recalling firm

Product type

Drug

Status

Completed

Report date

2024-07-17

Distribution

Nationwide in the USA and Puerto Rico

Firm state

Product quantity

n/a

Initiated by

Voluntary: Firm initiated

SPEQ quality domain

Environmental Monitoring

Reason for recall

Cross contamination with other products

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).

Code / lot info

Lot #: L300217, Exp. 04/31/2025.

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.