Drug product
Calcium Gluconate Ophthalmic Irrigation Solution 1%, 500 mL bags, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
D-0053-2024
Product summary
- Event
- Event 93154
- Status
- Terminated
- Classification
- Class II
- Quantity
- 128 bags
- Official record key
drug-enforcement:D-0053-2024
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: 69802, Exp. Date 02/28/2024
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility