Why it was recalled
CGMP Deviations
Product description
Alprostadil Container Description: Amber color bottle
Lot numbers, UPCs & expiration codes
Lot Numbers: HAALC0020922 exp. date AUG-2025
Where it was sold
Product was distributed to 3 distributors (1 Hong Kong and 2 accounts in Florida)
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0261-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Feb 7, 2025
- FDA report date
- Mar 19, 2025
- Quantity
- 3.0 gm
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Aspen Biopharma Labs Pvt., Ltd.
Original FDA data
Every field from FDA enforcement report D-0261-2025, exactly as published.
Show all FDA fields
- City
- Medchal Malkajgiri
- Status
- Ongoing
- Country
- India
- Event ID
- 96209
- Address
- Plot No 10, Biotech Park Phase-II
- Address (line 2)
- Lalgadi Malakpet Village,Turkapally, Shameerpet Mandal
- Code information
- Lot Numbers: HAALC0020922 exp. date AUG-2025
- Report date
- Mar 19, 2025
- Product type
- Drugs
- Recall number
- D-0261-2025
- Classification
- Class II
- Recalling firm
- Aspen Biopharma Labs Pvt., Ltd.
- Product quantity
- 3.0 gm
- Reason for recall
- CGMP Deviations
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Alprostadil Container Description: Amber color bottle
- Distribution pattern
- Product was distributed to 3 distributors (1 Hong Kong and 2 accounts in Florida)
- Recall initiation date
- Feb 7, 2025
- Initial firm notification
- Letter
- Center classification date
- Mar 9, 2025