Why it was recalled
Sub Potent
Product description
SB-4, Papaverine 30mg/mL, Phentolamine 3mg/mL, Alprostadil 40mcg/mL, packaged in a) 5 mL Multi-dose vial NDC 73198-0023-05; b) 10 mL Multi-dose vial NDC 73198-0023-10, Each ML contains: 0.5% Chlorobutanol NF, 0.0005% Edetate Disodium Dihydrate USP, 1.84% Benzyl Alcohol NF, 5% Mannitol USP, 1% Sodium Metabisulfite NF, 2% Ethyl Alcohol USP, Sterile Water for Injection USP, Rx Only, Olympia Pharmaceuticals, Conroy Rd., Ste. 155, Orlando, FL 32835
Lot numbers, UPCs & expiration codes
Lots: a) E41C18 Exp. 5/18/22; b) E41D18 Exp. 5/18/22
Where it was sold
Nationwide in the USA including Puerto Rico.
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-0722-2022
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Mar 8, 2022
- FDA report date
- Mar 30, 2022
- Quantity
- 1032 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Olympia Compounding Pharmacy dba Olympia Pharmacy
Original FDA data
Every field from FDA enforcement report D-0722-2022, exactly as published.
Show all FDA fields
- City
- Orlando
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 89717
- Address
- 6700 Conroy Rd Ste 155
- Code information
- Lots: a) E41C18 Exp. 5/18/22; b) E41D18 Exp. 5/18/22
- Postal code
- 32835-3515
- Report date
- Mar 30, 2022
- Product type
- Drugs
- Recall number
- D-0722-2022
- Classification
- Class III
- Recalling firm
- Olympia Compounding Pharmacy dba Olympia Pharmacy
- Product quantity
- 1032 vials
- Termination date
- Oct 4, 2023
- Reason for recall
- Sub Potent
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- SB-4, Papaverine 30mg/mL, Phentolamine 3mg/mL, Alprostadil 40mcg/mL, packaged in a) 5 mL Multi-dose vial NDC 73198-0023-05; b) 10 mL Multi-dose vial NDC 73198-0023-10, Each ML contains: 0.5% Chlorobutanol NF, 0.0005% Edetate Disodium Dihydrate USP, 1.84% Benzyl Alcohol NF, 5% Mannitol USP, 1% Sodium Metabisulfite NF, 2% Ethyl Alcohol USP, Sterile Water for Injection USP, Rx Only, Olympia Pharmaceuticals, Conroy Rd., Ste. 155, Orlando, FL 32835
- Distribution pattern
- Nationwide in the USA including Puerto Rico.
- Recall initiation date
- Mar 8, 2022
- Initial firm notification
- Letter
- Center classification date
- Mar 29, 2022