BIMIX-3, Papaverine 30 mg/mL . Phentolamine 3 mg/mL, 10 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0027-10.

Recall Number: D-0815-2022

Firm: Olympia Compounding Pharmacy dba Olympia Pharmacy

Classification: Class II

Status: Terminated

Report Date: 20220504

Initiation Date: 20220404

Termination Date: 20240617

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

BIMIX-3, Papaverine 30 mg/mL . Phentolamine 3 mg/mL, 10 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0027-10.