Recalling firm
Aspen Biopharma Labs Pvt., Ltd.
Product type
Drug
Status
Ongoing
Report date
2025-03-19
Distribution
Product was distributed to 3 distributors (1 Hong Kong and 2 accounts in Florida)
Product quantity
5.1 kg
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Risk Management & CAPAReason for recall
CGMP Deviations
Product description
Chlorambucil Container Description: The product packed in double self-seal cover and finally packed in Aluminum cover for shipping.
Code / lot info
Lot Numbers: HACUC0010722, exp. date Jun-2025 HACUC0010123, exp. date Dec-2025
Other recalls SPEQ maps to Risk Management & CAPA
See all Risk Management & CAPA recalls →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.