FDA-Drug2023-10-25Class II

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.

Pine Pharmaceuticals, LLC
Hazard

Lack of Assurance of Sterility

Sold states
Nationwide within the United States
Affected count
1693 droppers
Manufactured in
355 Riverwalk Pkwy, N/A, Tonawanda, NY, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0060-2024

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