FDAClass IISeptember 13, 2017

Timolol-Latanoprost PF Solution recall: Labeling Error

Timolol-Latanoprost PF Solution (0.5-0.005)%, Ophthalmic Drops, Sterile 5ml Bottle, Compounded for a licensed professional or patient use, imprimisRx…

Why was Timolol-Latanoprost PF Solution recalled?

Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier

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?

04042017@34B, 10/01/2017

Product
Timolol-Latanoprost PF Solution (0.5-0.005)%, Ophthalmic Drops, Sterile 5ml Bottle, Compounded for a licensed professional or patient use, imprimisRx…
Recalling firm
ImprimisRx CA, Inc., dba ImprimisRx
Quantity
16 bottles
Distribution
Nationwide
Recall date
September 13, 2017
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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