FDA-Drug2022-05-04Class II
NB-243, Papaverine 30mg/ml . Phentolamine 3mg/ml . Alprostadil 20mcg/ml, 10ml Multi-Dose vials, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0009-10
Olympia Compounding Pharmacy dba Olympia Pharmacy
Hazard
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
Sold states
Distributed Nationwide in the USA
Affected count
3509 vials
Manufactured in
6700 Conroy Rd Ste 155, Orlando, FL, United States
Products
NB-243, Papaverine 30mg/ml . Phentolamine 3mg/ml . Alprostadil 20mcg/ml, 10ml Multi-Dose vials, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0009-10
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0803-2022Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief