D-0265-2025 Class II Ongoing

Recalled by Aspen Biopharma Labs Pvt., Ltd. — Medchal Malkajgiri

FDA drug recall D-0265-2025 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: 4.0 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
4.0 kg

Product Description

Voriconazole Container Description: voriconazole 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 Number: HAVZC0020922, exp. date AUG-2026