FDA recall D-0060-2024

Pine Pharmaceuticals, LLC · Class II · 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.

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-0060-2024