Product: PGE-1, Alprostadil 40 mcg/mL, 10ml Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0028-10.
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