The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1107-2022·Announced 2022-06-15

Polymyxin B and Trimethoprim Ophthalmic Solution Recalled Due to Temperature Abuse

McKesson Medical-Surgical is recalling Polymyxin B and Trimethoprim Ophthalmic Solution nationwide due to temperature deviations during manufacturing. The medication may not work as intended.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: FDA Class II recall for manufacturing quality deviations with no reported illnesses or injuries. This is a precautionary recall where the hazard—potential loss of medication efficacy—is theoretical and does not involve documented harm.

Plain-English summary

McKesson Medical-Surgical Inc. is recalling Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution, USP, sterile 0.1%, 10 mL bottles, Rx only, due to cGMP (current Good Manufacturing Practice) deviations involving temperature abuse. The product was manufactured by Sandoz Pharma.

Temperature deviations during manufacturing may affect the stability and effectiveness of these antibiotic eye drops. Polymyxin B and Trimethoprim are used to treat bacterial eye infections.

The recalled product was distributed nationwide in the USA, affecting approximately 44 bottles. McKesson Medical-Surgical is unable to determine specific lot numbers or which customers received affected product. Each customer notification included the distribution date and shipment dates of potentially affected product.

Patients and healthcare providers should discontinue use of the recalled medication and contact a healthcare provider or pharmacist for a replacement. The recalled product can be identified by NDC code 6131462810.

The recalled product

Product
Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution, USP, sterile, 0.1%, 10 mL bottle, Rx only, MFG: Sandoz Pharma, NDC 6131462810
Manufacturer
Mckesson Medical-Surgical Inc. Corporate Office
Category
Drug
Hazard
Affected units
44

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 130 recalled by Mckesson Medical-Surgical Inc. Corporate Office under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 130 products in this recall →

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