FDA Drug recall D-0060-2024
TPC Drops (tropicamide 1%- phenylephrine 2.5%- cyclopentolate HCl 1% ophthalmic solution, 5 mL droppers, Rx only, Compounded by Pine Pharma…
- FDA Drug
- Class II
- terminated
- Published 2023-10-25
On 2023-10-25 the FDA classified a Class II recall of TPC Drops (tropicamide 1%- phenylephrine 2.5%- cyclopentolate HCl 1% ophthalmic solution, 5 mL droppers, Rx only, Compounded by Pine Pharma… by Pine Pharmaceuticals, citing lack of Assurance of Sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0060-2024 |
| 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
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.
Reason
Lack of Assurance of Sterility
Identifiers
| code_info | Lot #: 68184, Exp. Date 10/9/2023; 68623, Exp. Date 11/2/2023 |
|---|
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-0060-2024%22
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