FDAClass IIJune 2, 2021

Tobrex 0.3% 3.5gm Opth recall: CGMP Deviations

TOBREX 0.3% 3.5GM OPTH; NDC/UPC 65064435; RX; OINTMENT

Why was Tobrex 0.3% 3.5gm Opth recalled?

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

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?

20B14E

Product
TOBREX 0.3% 3.5GM OPTH; NDC/UPC 65064435; RX; OINTMENT
Recalling firm
Cardinal Health Inc.
Quantity
28 tubes
Distribution
FL, GA, SC
Recall date
June 2, 2021
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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