FDAClass IDecember 31, 2014

Tropi/Cyclo/Phenyl/Tobra/Flurb recall: Sterility Concern

Tropi/Cyclo/Phenyl/Tobra/Flurb (1/1/10/0.3/0.03)% Sterile Ophthalmic Solution, 1 mL Dropper in a 3 mL bottle, Rx only, Pharmacy Creations, Randolph…

Why was Tropi/Cyclo/Phenyl/Tobra/Flurb recalled?

Non-Sterility: Failing sterility results were obtained from the recalling firm's contract testing facility indicating that the products may not be sterile.

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 #: 05202014@3, Exp 11/16/2014

Product
Tropi/Cyclo/Phenyl/Tobra/Flurb (1/1/10/0.3/0.03)% Sterile Ophthalmic Solution, 1 mL Dropper in a 3 mL bottle, Rx only, Pharmacy Creations, Randolph…
Recalling firm
Pharmacy Creations
Quantity
50 bottles
Distribution
Directly to patients and physicians in FL, NJ, NY, and Puerto Rico
Recall date
December 31, 2014
Classification
Class I
Status
Terminated
Agency
FDA (drug)
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