FDAClass IIOctober 25, 2023

Tropi-Phen recall: Sterility Concern

Tropi-Phen (tropicamide 1%, phenylephrine 2.5%) ophthalmic solution, 5mL multi-use dropper, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk…

Why was Tropi-Phen recalled?

Lack of Assurance of Sterility

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: 67659, Exp. Date 10/16/2023; 70316, Exp. Date 1/30/2024

Product
Tropi-Phen (tropicamide 1%, phenylephrine 2.5%) ophthalmic solution, 5mL multi-use dropper, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk…
Recalling firm
Pine Pharmaceuticals, LLC
Quantity
662 dropper
Distribution
Nationwide within the United States
Recall date
October 25, 2023
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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