Recall D-0901-2022
Description: SB-6 Papaverine 30 mg/mL Phentolamine 3 mg/mL PGE 60 mcg/mL, Packaged in a) 5 mL Multi-Dose vial, NDC 73198-0025-05; b) 10 mL, Multi-Dose vial, NDC 73198-0025-10; Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835
Recall D-0901-2022 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | D-0901-2022 |
Event ID | 90204 |
Distribution | Distributed Nationwide in th USA, Puerto Rico and US Virgin Islands |
Quantity | 874 vials |
Recall Reason | Lack of assurance of sterility. |
Drug Classification | Class II |
Drug Code Info | 20220601 |
Recall Initiation Date | 20220509 |
Report Date | 20220601 |
Classification Date | 20220525 |
Address | 6700 Conroy Rd Ste 155 Orlando, FL 32835-3515 United States |
Recalling Firm | Olympia Compounding Pharmacy dba Olympia Pharmacy |
Initial Notification | Letter |
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