FDA recall D-0063-2024

Pine Pharmaceuticals, LLC · Class II · 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.

Reason for recall

Lack of Assurance of Sterility

Distribution

Nationwide within the United States

Key facts

Status: Terminated
Initiation date: 2023-10-02
Report date: 2023-10-25
Termination date: 2024-05-15
Voluntary/Mandated: Voluntary: Firm initiated
Location: Tonawanda, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0063-2024