FDAFDA · Food and drugs·Recall number D-0800-2022
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
Published May 4, 2022 · Recall initiated: April 4, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Olympia Compounding Pharmacy dba Olympia Pharmacy
- Distributor
- Distributed Nationwide in the USA
- Lot
- Lots: D41C19 BUD: 4/19/2022, I42C13 BUD: 9/13/2022, I42B13 BUD: 9/13/2022
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.