PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: June 15, 2022 Initiated: April 13, 2022 #D-1107-2022

Product Description

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

Reason for Recall

cGMP deviations: Temperature abuse

Details

Units Affected
44 bottles
Distribution
USA nationwide.
Location
Richmond, VA

Frequently Asked Questions

What product was recalled?
Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution, USP, sterile, 0.1%, 10 mL bottle, Rx only, MFG: Sandoz Pharma, NDC 6131462810. Recalled by Mckesson Medical-Surgical Inc. Corporate Office. Units affected: 44 bottles.
Why was this product recalled?
cGMP deviations: Temperature abuse
Which agency issued this recall?
This recall was issued by the FDA Drug on June 15, 2022. Severity: Moderate. Recall number: D-1107-2022.