FDA-Drug2022-05-04Class II
Diluent for Reconstitution Each ML contains: 1.5% Benzyl Alcohol NF, Sterile Water for Injection USP, 10 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Conroy Rd., Ste. 155, Orlando, FL 32835. 73198-0113-10
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
45,935 vials
Manufactured in
6700 Conroy Rd Ste 155, Orlando, FL, United States
Products
Diluent for Reconstitution Each ML contains: 1.5% Benzyl Alcohol NF, Sterile Water for Injection USP, 10 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Conroy Rd., Ste. 155, Orlando, FL 32835. 73198-0113-10
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0796-2022Don't want to check this manually?
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