Tropi-Phen ophthalmic solution recalled over sterility concerns
- Recall date
- October 2, 2023
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Pine Pharmaceuticals, LLC recalls Tropi-Phen (tropicamide 1%, phenylephrine 2.5%) ophthalmic solution, 5mL multi-use dropper, Rx only, Compounded by Pine…
- Recall number
- D-0063-2024
- FDA classification
- Class II
- Brand / firm
- Pine Pharmaceuticals, LLC
- Sold / distributed
- Nationwide within the United States
Why it was recalled
Lack of Assurance of Sterility
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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.
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