FDAClass IIJune 15, 2022

Polymyxin B Sulfate and Trimethoprim Ophthalmic recall: CGMP Deviations

Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution, USP, sterile, 0.1%, 10 mL bottle, Rx only, MFG: Sandoz Pharma, NDC 6131462810

Why was Polymyxin B Sulfate and Trimethoprim Ophthalmic recalled?

cGMP deviations: Temperature abuse

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?

McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Product
Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution, USP, sterile, 0.1%, 10 mL bottle, Rx only, MFG: Sandoz Pharma, NDC 6131462810
Recalling firm
Mckesson Medical-Surgical Inc. Corporate Office
Quantity
44 bottles
Distribution
USA nationwide.
Recall date
June 15, 2022
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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