D-0263-2025 Class II Ongoing
FDA drug recall D-0263-2025 was initiated by Aspen Biopharma Labs Pvt., Ltd. on February 7, 2025 and is designated Class II. Reason for recall: CGMP Deviations The recall status is ongoing. Affected quantity: 5.1 kg.
Recall Details
- Product Type
- Drugs
- Report Date
- March 19, 2025
- Initiation Date
- February 7, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5.1 kg
Product Description
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 Pattern
Product was distributed to 3 distributors (1 Hong Kong and 2 accounts in Florida)
Code Information
Lot Numbers: HACUC0010722, exp. date Jun-2025 HACUC0010123, exp. date Dec-2025