FDA-Drug2022-06-01Class II
RE-2 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 300 mcg/mL, Packaged as a) 2.5 mL Multi Dose vial, NDC 73198-0016-03; b) 10 mL Multi Dose vial, NDC 73198-0016-10; Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835
Olympia Compounding Pharmacy dba Olympia Pharmacy
Hazard
Lack of assurance of sterility.
Sold states
Distributed Nationwide in th USA, Puerto Rico and US Virgin Islands
Affected count
1710 vials
Manufactured in
6700 Conroy Rd Ste 155, Orlando, FL, United States
Products
RE-2 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 300 mcg/mL, Packaged as a) 2.5 mL Multi Dose vial, NDC 73198-0016-03; b) 10 mL Multi Dose vial, NDC 73198-0016-10; Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0899-2022Don't want to check this manually?
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