Recall D-0798-2022
Description: QM-2 Papaverine 30 mg/mL. Phentolamine 3 mg/mL . Alprostadil 60 mcg/mL . Atropine 0.2 mg/mL, Multi-Dose 10 mL vial, Rx Only Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC: 73198-0018-10.
Recall D-0798-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0798-2022 |
| Event ID | 89938 |
| Distribution | Distributed Nationwide in the USA |
| Quantity | 1871 vials |
| Recall Reason | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated |
| Drug Classification | Class II |
| Drug Code Info | 20220504 |
| Recall Initiation Date | 20220404 |
| Report Date | 20220504 |
| Classification Date | 20220427 |
| Address | 6700 Conroy Rd Ste 155 Orlando, FL 32835-3515 United States |
| Recalling Firm | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| Initial Notification | Letter |
| Similar To |