The Recall Desk

FDA (Drugs) recall action 94922

Zydus Pharmaceuticals (USA) Inc recalled 2 products on 2024-07-17

The FDA (Drugs) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2024-07-17
Critical
0
Units
12,720

Why these products were recalled

Cross contamination with other products

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • ModerateFDA (Drugs)··2024-07-17

    Micafungin injection vials recalled for cross-contamination

    Zydus Pharmaceuticals is recalling Micafungin for injection (100 mg/vial, Lot #L300220) due to potential cross-contamination with other products. Approximately 12,720 vials distributed nationwide in the USA and Puerto Rico are affected.

    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).
    Category
    Distribution
    1 state
  • ModerateFDA (Drugs)··2024-07-17

    Micafungin for Injection Recalled for Cross Contamination Risk

    Zydus Pharmaceuticals recalls Micafungin for injection (Lot L300217) distributed nationwide due to potential cross contamination with other products. No illnesses have been reported.

    Product
    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).
    Category
    Distribution
    1 state