Why it was recalled
Sub Potent
Product description
Formula F9, Papaverine 0.9 mg/mL, Phentolamine 0.1 mg/mL, PGE 20 mcg/mL, Atropine 0.01 mg/mL, Multi-Dose 10 mL vial, Each ML contains: 0.5% Chlorobutanol NF, 0.005% Edetate Disodium Dihydrate USP, 2.74% Benzyl Alcohol NF, 5% Mannitol USP, 1% Sodium Metabisulfite NF, 1% Ethyl Alcohol USP, Sterile Water for Injection USP, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0004-10
Lot numbers, UPCs & expiration codes
Lot: D41C19 Exp. 4/19/22
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-0720-2022
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Mar 8, 2022
- FDA report date
- Mar 30, 2022
- Quantity
- 493 vials.
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Olympia Compounding Pharmacy dba Olympia Pharmacy
Original FDA data
Every field from FDA enforcement report D-0720-2022, 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
- Lot: D41C19 Exp. 4/19/22
- Postal code
- 32835-3515
- Report date
- Mar 30, 2022
- Product type
- Drugs
- Recall number
- D-0720-2022
- Classification
- Class III
- Recalling firm
- Olympia Compounding Pharmacy dba Olympia Pharmacy
- Product quantity
- 493 vials.
- Termination date
- Oct 4, 2023
- Reason for recall
- Sub Potent
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Formula F9, Papaverine 0.9 mg/mL, Phentolamine 0.1 mg/mL, PGE 20 mcg/mL, Atropine 0.01 mg/mL, Multi-Dose 10 mL vial, Each ML contains: 0.5% Chlorobutanol NF, 0.005% Edetate Disodium Dihydrate USP, 2.74% Benzyl Alcohol NF, 5% Mannitol USP, 1% Sodium Metabisulfite NF, 1% Ethyl Alcohol USP, Sterile Water for Injection USP, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0004-10
- 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