Aspen Biopharma Labs Pvt. product recalled over manufacturing violations
- Recall date
- February 7, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Aspen Biopharma Labs Pvt., Ltd. recalls Voriconazole Container Description: voriconazole The product packed in white poly bag containing black poly bag and tie…
- Recall number
- D-0265-2025
- FDA classification
- Class II
- Brand / firm
- Aspen Biopharma Labs Pvt., Ltd.
- Sold / distributed
- Product was distributed to 3 distributors (1 Hong Kong and 2 accounts in Florida)
Why it was recalled
CGMP Deviations
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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.
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