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.
D-0052-2024
Product summary
- Event
- Event 93154
- Status
- Terminated
- Classification
- Class II
- Quantity
- 201 kits
- Official record key
drug-enforcement:D-0052-2024
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: 69986, Exp. Date 11/15/2023
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility