Olympia Compounding Pharmacy dba Olympia Pharmacy recalls SB-5, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . PGE 50 mcg/mL, 10 mL, Multi-Dose vial, Rx Only, Olympia Pharmaceutica
Recalled May 4, 2022 · FDA recall D-0807-2022 · Olympia Compounding Pharmacy
Hazard
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated · FDA Class II
Units
1110 vials
Sold at
Distributed Nationwide in the USA
Description
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
Product
SB-5, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . PGE 50 mcg/mL, 10 mL, Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0024-10.
Manufacturer(s)
Olympia Compounding Pharmacy dba Olympia Pharmacy
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →