Why it was recalled
Lack of Assurance of Sterility
Product description
Alprostadil (prostaglandin E1) 80 MCG/ML Injectable, For Intracavernosal Use, Freeze, 2.5 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0543-2
Lot numbers, UPCs & expiration codes
Lot #: 11112019+53208, Exp 4/29/2020
Where it was sold
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
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-0936-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 15, 2020
- FDA report date
- Mar 11, 2020
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
Original FDA data
Every field from FDA enforcement report D-0936-2020, exactly as published.
Show all FDA fields
- City
- Los Angeles
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 84978
- Address
- 1990 Westwood Blvd Ste 135
- Code information
- Lot #: 11112019+53208, Exp 4/29/2020
- Postal code
- 90025-4650
- Report date
- Mar 11, 2020
- Product type
- Drugs
- Recall number
- D-0936-2020
- Classification
- Class II
- Recalling firm
- Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
- Termination date
- Dec 7, 2023
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Alprostadil (prostaglandin E1) 80 MCG/ML Injectable, For Intracavernosal Use, Freeze, 2.5 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0543-2
- Distribution pattern
- U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
- Recall initiation date
- Jan 15, 2020
- Initial firm notification
- Press Release
- Center classification date
- Mar 5, 2020