D-0596-2024 Class III

Recalled by Zydus Pharmaceuticals (USA) Inc — Pennington, NJ

FDA drug recall D-0596-2024 was initiated by Zydus Pharmaceuticals (USA) Inc on Jul 2, 2024 and is designated Class III. Reason for recall: Cross contamination with other products

Recall Details

Product Type
Drugs
Report Date
Jul 17, 2024
Initiation Date
Jul 2, 2024
Voluntary/Mandated
Voluntary: Firm initiated

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).

Reason for Recall

Cross contamination with other products

Distribution Pattern

Nationwide in the USA and Puerto Rico

Code Information

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

Source

Dataset
openFDA drug recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for D-0596-2024
openFDA file date
Oct 23, 2026
Loaded by RegDataLab
Oct 26, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.