Compounded Injectable Drug Recalled Due to Manufacturing Process Violations
Olympia Compounding Pharmacy is recalling 1,849 vials of RE-1, a compounded injectable medication, due to CGMP deviations in environmental and personnel monitoring. Monitoring excursions were not properly investigated prior to October 2021.
- Product
- RE-1, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . Alprostadil 200 mcg/mL, Packaged in a) 10 mL Multi-Dose vial, NDC 73198-0015-10; b) 2.5 mL Multi-Dose vial, NDC 73198-0015-03; Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835.
- Category
- Drug
- Distribution
- Distributed nationwide