Drug product
Calcium Gluconate 2.5% solution for inhalation, 5mL pre-filled syringes, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
D-0054-2024
Product summary
- Event
- Event 93154
- Status
- Terminated
- Classification
- Class II
- Quantity
- 881 pre-filled syringes
- Official record key
drug-enforcement:D-0054-2024
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: 70363, Exp. Date 03/20/2024
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility