Why it was recalled
Lack of assurance of sterility.
Product description
Formula F1 Papaverine 1.8 mg/mL Phentolamine 0.2 mg/mL Alprostadil 18 mcg/mL Atropine 0.02 mg/mL, Packaged as a)2.5 mL Multi-Dose vial, NDC 73198-0001-03; b) 10 mL Multi-Dose vial, NDC 73198-0001-10; Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835
Lot numbers, UPCs & expiration codes
Lots: K41C09, K41B09 BUD: 11/9/2022, and A24C19-22 BUD: 1/19/2023
Where it was sold
Distributed Nationwide in th USA, Puerto Rico and US Virgin Islands
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-0927-2022
- Classification
- Class II
- Status
- Completed
- Recall initiated
- May 9, 2022
- FDA report date
- Jun 1, 2022
- Quantity
- 1703 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Olympia Compounding Pharmacy dba Olympia Pharmacy
Original FDA data
Every field from FDA enforcement report D-0927-2022, exactly as published.
Show all FDA fields
- City
- Orlando
- State
- FL
- Status
- Completed
- Country
- United States
- Event ID
- 90204
- Address
- 6700 Conroy Rd Ste 155
- Code information
- Lots: K41C09, K41B09 BUD: 11/9/2022, and A24C19-22 BUD: 1/19/2023
- Postal code
- 32835-3515
- Report date
- Jun 1, 2022
- Product type
- Drugs
- Recall number
- D-0927-2022
- Classification
- Class II
- Recalling firm
- Olympia Compounding Pharmacy dba Olympia Pharmacy
- Product quantity
- 1703 vials
- Reason for recall
- Lack of assurance of sterility.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Formula F1 Papaverine 1.8 mg/mL Phentolamine 0.2 mg/mL Alprostadil 18 mcg/mL Atropine 0.02 mg/mL, Packaged as a)2.5 mL Multi-Dose vial, NDC 73198-0001-03; b) 10 mL Multi-Dose vial, NDC 73198-0001-10; Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835
- Distribution pattern
- Distributed Nationwide in th USA, Puerto Rico and US Virgin Islands
- Recall initiation date
- May 9, 2022
- Initial firm notification
- Letter
- Center classification date
- May 25, 2022