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 F9, Papaverine 0.9mg/ml . Phentolamine 0.1mg/ml . PGE 20mcg/mL Atropine 0.01mg/ml, Multi-Dose 10 ml vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC: 73198-0004-10
Lot numbers, UPCs & expiration codes
Lots: D41C19 BUD: 4/19/2022, I42C13 BUD: 9/13/2022, I42B13 BUD: 9/13/2022
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-0800-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 4, 2022
- FDA report date
- May 4, 2022
- Quantity
- 800 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Olympia Compounding Pharmacy dba Olympia Pharmacy
Original FDA data
Every field from FDA enforcement report D-0800-2022, 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: D41C19 BUD: 4/19/2022, I42C13 BUD: 9/13/2022, I42B13 BUD: 9/13/2022
- Postal code
- 32835-3515
- Report date
- May 4, 2022
- Product type
- Drugs
- Recall number
- D-0800-2022
- Classification
- Class II
- Recalling firm
- Olympia Compounding Pharmacy dba Olympia Pharmacy
- Product quantity
- 800 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 F9, Papaverine 0.9mg/ml . Phentolamine 0.1mg/ml . PGE 20mcg/mL Atropine 0.01mg/ml, Multi-Dose 10 ml vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC: 73198-0004-10
- Distribution pattern
- Distributed Nationwide in the USA
- Recall initiation date
- Apr 4, 2022
- Initial firm notification
- Letter
- Center classification date
- Apr 27, 2022