Drug product
Tropi-Phen (tropicamide 1%, phenylephrine 2.5%) ophthalmic solution, 5mL multi-use dropper, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
D-0063-2024
Product summary
- Event
- Event 93154
- Status
- Terminated
- Classification
- Class II
- Quantity
- 662 dropper
- Official record key
drug-enforcement:D-0063-2024
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: 67659, Exp. Date 10/16/2023; 70316, Exp. Date 1/30/2024
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility