FDA recall D-0808-2022

Olympia Compounding Pharmacy dba Olympia Pharmacy · Class II · drug

Product

SB-6, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . PGE 60 mcg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0025-10.

Reason for recall

CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated

Distribution

Distributed Nationwide in the USA

Key facts

Status: Terminated
Initiation date: 2022-04-04
Report date: 2022-05-04
Termination date: 2024-06-17
Voluntary/Mandated: Voluntary: Firm initiated
Location: Orlando, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0808-2022