D-0262-2025 Class II Ongoing
FDA drug recall D-0262-2025 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: 120.0 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
- 120.0 kg
Product Description
Finasteride NDC# 82187-1003-1 Container Description: The product packed in white poly bag containing black poly bag and tied each individual finally packed in HDPE container 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: HAFSC0040923, exp. date Aug-2027 HAFSC0050923, exp. date Aug-2027