Olympia Compounding Pharmacy dba Olympia Pharmacy recalls Sincalide. Lyophilized powder for reconstitution. 5 mcg per Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convo
Recalled May 4, 2022 · FDA recall D-0827-2022 · 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
1770 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
Sincalide. Lyophilized powder for reconstitution. 5 mcg per Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0082-00.
Manufacturer(s)
Olympia Compounding Pharmacy dba Olympia Pharmacy
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →