FDAFDA · Food and drugs·Recall number D-0927-2022
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
Published June 1, 2022 · Recall initiated: May 9, 2022
Status when published: Completed — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of assurance of sterility.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Olympia Compounding Pharmacy dba Olympia Pharmacy
- Distributor
- Distributed Nationwide in th USA, Puerto Rico and US Virgin Islands
- Lot
- Lots: K41C09, K41B09 BUD: 11/9/2022, and A24C19-22 BUD: 1/19/2023
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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