FDA Recalls Compounded Injectable Drug Formula F9 Due to CGMP Violations
The FDA is recalling Formula F9, a compounded injectable medication, due to manufacturing control failures. Environmental and personnel monitoring protocols were not properly followed, which could allow contamination.
- Product
- Formula F9, Papaverine 0.9mg/ml . Phentolamine 0.1mg/ml . PGE 20mcg/mL Atropine 0.01mg/ml, Multi-Dose 10 ml vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC: 73198-0004-10
- Category
- Drug
- Distribution
- Distributed nationwide