FDAHealthFebruary 7, 2025
Aspen Biopharma Labs Pvt., Ltd. — Alprostadil Container Description: Amber color bottle
⚠️ CGMP Deviations
Is this relevant to me?
- Geography
- Unknown
- Source agency
- FDA
- Category
- Health
- Published
- February 7, 2025
Product was distributed to 3 distributors (1 Hong Kong and 2 accounts in Florida)
What's affected?
- Product
- Alprostadil Container Description: Amber color bottle
- Lot code
- HAALC0020922
Additional details
Lot Numbers: HAALC0020922 exp. date AUG-2025
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 3.0 gm.
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