FDA-Drug2022-05-04Class II
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.
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
1770 vials
Manufactured in
6700 Conroy Rd Ste 155, Orlando, FL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0827-2022Don't want to check this manually?
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