Why it was recalled
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
Product description
Formula F2, Papaverine 9 mg/mL . Phentolamine 1 mg/mL . Alprostadil 10 mcg/mL . Atropine 0.1 mg/mL, 10 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0002-10.
Lot numbers, UPCs & expiration codes
Lots: G48C20 BUD: 7/20/2022, G48B20 BUD: 7/22/2022
Where it was sold
Distributed Nationwide in the USA
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-0821-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 4, 2022
- FDA report date
- May 4, 2022
- Quantity
- 257 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Olympia Compounding Pharmacy dba Olympia Pharmacy
Original FDA data
Every field from FDA enforcement report D-0821-2022, exactly as published.
Show all FDA fields
- City
- Orlando
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 89938
- Address
- 6700 Conroy Rd Ste 155
- Code information
- Lots: G48C20 BUD: 7/20/2022, G48B20 BUD: 7/22/2022
- Postal code
- 32835-3515
- Report date
- May 4, 2022
- Product type
- Drugs
- Recall number
- D-0821-2022
- Classification
- Class II
- Recalling firm
- Olympia Compounding Pharmacy dba Olympia Pharmacy
- Product quantity
- 257 vials
- Termination date
- Jun 17, 2024
- Reason for recall
- CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Formula F2, Papaverine 9 mg/mL . Phentolamine 1 mg/mL . Alprostadil 10 mcg/mL . Atropine 0.1 mg/mL, 10 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0002-10.
- Distribution pattern
- Distributed Nationwide in the USA
- Recall initiation date
- Apr 4, 2022
- Initial firm notification
- Letter
- Center classification date
- Apr 27, 2022