FDAClass IIJanuary 25, 2023

AK-POLY-BAC brand of Bacitracin cand Polymixin B recall: CGMP Deviations

AK-POLY-BAC brand of Bacitracin cand Polymixin B Sulfate Ophthalmic Ointment USP, 3.5 g (1/8 oz.) tube, Rx only, Sterile, Manufactured by: Akorn…

Why was AK-POLY-BAC brand of Bacitracin cand Polymixin B recalled?

CGMP Deviations:

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA 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 # 0G87A, EXP 06/30/2023

Product
AK-POLY-BAC brand of Bacitracin cand Polymixin B Sulfate Ophthalmic Ointment USP, 3.5 g (1/8 oz.) tube, Rx only, Sterile, Manufactured by: Akorn…
Recalling firm
Akorn, Inc.
Quantity
36,025 tubes
Distribution
Nationwide in the USA
Recall date
January 25, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
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