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Recall Observatory FDA recall evidence

Drug product

Chlorambucil Container Description: The product packed in double self-seal cover and finally packed in Aluminum cover for shipping.

D-0263-2025

February 07, 2025

Class II

Product summary

Firm
Aspen Biopharma Labs Pvt., Ltd.
Event
Event 96209
Status
Ongoing
Classification
Class II
Quantity
5.1 kg
Official record key
drug-enforcement:D-0263-2025

Official wording

Reason: CGMP Deviations

Code information: Lot Numbers: HACUC0010722, exp. date Jun-2025 HACUC0010123, exp. date Dec-2025

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