Product: 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.
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
Recall initiated: 20220404
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated