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Recall Observatory FDA recall evidence

Drug product

Voriconazole Container Description: voriconazole The product packed in white poly bag containing black poly bag and tied each individual finally packed in HDPE container for shipping.

D-0265-2025

February 07, 2025

Class II

Product summary

Firm
Aspen Biopharma Labs Pvt., Ltd.
Event
Event 96209
Status
Ongoing
Classification
Class II
Quantity
4.0 kg
Official record key
drug-enforcement:D-0265-2025

Official wording

Reason: CGMP Deviations

Code information: Lot Number: HAVZC0020922, exp. date AUG-2026

Distribution pattern: Product was distributed to 3 distributors (1 Hong Kong and 2 accounts in Florida)

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations