FDA recall D-0263-2025

Aspen Biopharma Labs Pvt., Ltd. · Class II · drug

Product

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

Reason for recall

CGMP Deviations

Distribution

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

Key facts

Status
Ongoing
Initiation date
2025-02-07
Report date
2025-03-19
Voluntary/Mandated
Voluntary: Firm initiated
Location
Medchal Malkajgiri, India

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0263-2025