Drug product
TPC Drops (tropicamide 1%- phenylephrine 2.5%- cyclopentolate HCl 1% ophthalmic solution, 5 mL droppers, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
D-0060-2024
Product summary
- Event
- Event 93154
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1693 droppers
- Official record key
drug-enforcement:D-0060-2024
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: 68184, Exp. Date 10/9/2023; 68623, Exp. Date 11/2/2023
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility