FDA Drug recall D-0055-2024
Tropi-Phen (Tropicamide 1% phenylephrine HCl 2.5%) ophthalmic solution, 15 mL multi-use Droppers, Rx only, Compounded by Pine Pharmaceutica…
- FDA Drug
- Class II
- terminated
- Published 2023-10-25
On 2023-10-25 the FDA classified a Class II recall of Tropi-Phen (Tropicamide 1% phenylephrine HCl 2.5%) ophthalmic solution, 15 mL multi-use Droppers, Rx only, Compounded by Pine Pharmaceutica… by Pine Pharmaceuticals, citing lack of Assurance of Sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0055-2024 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2023-10-02 |
| Published | 2023-10-25 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Pine Pharmaceuticals |
| Distribution | US |
Product
Tropi-Phen (Tropicamide 1% phenylephrine HCl 2.5%) ophthalmic solution, 15 mL multi-use Droppers, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
Reason
Lack of Assurance of Sterility
Identifiers
| code_info | Lot #: 67008, Exp. Date 10/04/2023; 67685, Exp. Date 10/21/2023; 67853, Exp. Date 10/25/2023; 69967, Exp. Date 01/13/2024 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0055-2024%22
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