Olympia Compounding Pharmacy dba Olympia Pharmacy recalls Sermorelin Acetate, Lyophilized powder for reconstitution, Multi-Dose vials, Packaged as a) 3 mg per vial, NDC 73198-006
Recalled May 4, 2022 · FDA recall D-0797-2022 · 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
18060 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
Sermorelin Acetate, Lyophilized powder for reconstitution, Multi-Dose vials, Packaged as a) 3 mg per vial, NDC 73198-0060-00; b) 9 mg NDC 73198-0059-00, Rx Only, Olympia Pharmaceuticals 6700 Conroy Rd., Ste. 155, Orlando, FL 32835.
Manufacturer(s)
Olympia Compounding Pharmacy dba Olympia Pharmacy
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →