Drug product
Lidocaine HCl 4% ophthalmic solution, 3 mL single-use dropper, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
D-0062-2024
Product summary
- Event
- Event 93154
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1598 droppers
- Official record key
drug-enforcement:D-0062-2024
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: 67443, Exp. Date 10/8/2023; 68775, Exp. Date 12/9/2023
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility