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 Bimatoprost NDC# 82187-1001-1 Container description: The product packed in double self-seal cover and finally packed in…
- Recall number
- D-0260-2025
- 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
Bimatoprost NDC# 82187-1001-1 Container description: The product packed in double self-seal cover and finally packed in Aluminum cover for shipping.
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