Why it was recalled
Lack of Assurance of Sterility
Product description
Alprostadil 10mcg/Papaverine 30mg/Phentolamine 1mg/ml lnj Soln, 5 mL, Injectable, Rx only, INNOVATIVE COMPOUNDING PHARMACY, 41536 EASTMAN DRIVE SUITE A MURRIETA , CA 92562 951-304-9530
Lot numbers, UPCs & expiration codes
Lot #02282020@30, Expires after 04/28/2020
Where it was sold
Patient Distribution list includes addresses in the following states: CA, ME, TX
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-1099-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 26, 2020
- FDA report date
- Apr 15, 2020
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy
Original FDA data
Every field from FDA enforcement report D-1099-2020, exactly as published.
Show all FDA fields
- City
- Murrieta
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 85351
- Address
- 41538 Eastman Dr Ste A
- Code information
- Lot #02282020@30, Expires after 04/28/2020
- Postal code
- 92562-8007
- Report date
- Apr 15, 2020
- Product type
- Drugs
- Recall number
- D-1099-2020
- Classification
- Class II
- Recalling firm
- Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy
- Termination date
- Jan 29, 2024
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Alprostadil 10mcg/Papaverine 30mg/Phentolamine 1mg/ml lnj Soln, 5 mL, Injectable, Rx only, INNOVATIVE COMPOUNDING PHARMACY, 41536 EASTMAN DRIVE SUITE A MURRIETA , CA 92562 951-304-9530
- Distribution pattern
- Patient Distribution list includes addresses in the following states: CA, ME, TX
- Recall initiation date
- Mar 26, 2020
- Initial firm notification
- Letter
- Center classification date
- Apr 6, 2020