FDAClass IIOctober 25, 2023

TPC Drops recall: Sterility Concern

TPC Drops (tropicamide 1%- phenylephrine 2.5%- cyclopentolate HCl 1% ophthalmic solution, 5 mL droppers, Rx only, Compounded by Pine Pharmaceuticals…

Why was TPC Drops 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 #: 68184, Exp. Date 10/9/2023; 68623, Exp. Date 11/2/2023

Product
TPC Drops (tropicamide 1%- phenylephrine 2.5%- cyclopentolate HCl 1% ophthalmic solution, 5 mL droppers, Rx only, Compounded by Pine Pharmaceuticals…
Recalling firm
Pine Pharmaceuticals, LLC
Quantity
1693 droppers
Distribution
Nationwide within the United States
Recall date
October 25, 2023
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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