FDA recall D-0052-2024
Pine Pharmaceuticals, LLC · Class II · drug
Product
Endophth Kit (Vancomycin 1mg/0.1 mL - Ceftazidime 2.25mg/0.1 mL), Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
Reason for recall
Lack of Assurance of Sterility
Distribution
Nationwide within the United States
Key facts
- Status
- Terminated
- Initiation date
- 2023-10-02
- Report date
- 2023-10-25
- Termination date
- 2024-05-15
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Tonawanda, NY, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0052-2024