Mckesson Medical-Surgical recalls 500mL BSS Sterile Irrigating Solution (Rx only) due to temperature abuse risks. Products may have been shipped with improper temperature control.
cGMP deviations: Temperature abuse
Mckesson Medical-Surgical is recalling 500mL BSS Sterile Irrigating Solution bottles that may have been exposed to improper temperatures. This could affect the solution's safety and effectiveness for medical use.
The product was manufactured under cGMP (current Good Manufacturing Practice) deviations related to temperature abuse. This means the solution may have been exposed to temperatures that could compromise its sterility and safety.
Healthcare providers and patients who use this prescription medication for medical procedures. Those who received the product through McKesson Medical-Surgical may be affected.
The product is a 500mL bottle of BSS Sterile Irrigating Solution (balanced salt solution) that requires a prescription. It was manufactured by Alcon Surgical Inc and distributed by McKesson Medical-Surgical.
Look for the NDC code 0065-0795-50 on the product label to confirm it is part of this recall.
The recall indicates potential temperature abuse during manufacturing, which could compromise safety. The product may not be safe for medical use.
The product is a 500mL bottle of BSS Sterile Irrigating Solution (balanced salt solution) with NDC 0065-0795-50, distributed by McKesson Medical-Surgical.
The recall does not specify a remedy, so contact your healthcare provider for guidance on whether to use the product.
We’ve drafted a message you can send Mckesson Medical-Surgical to request your refund or repair — edit it as you like.
Subject: Recall D-1034-2022 — Mckesson Medical-Surgical Mckesson Medical-Surgical Hello, I own a Mckesson Medical-Surgical that is covered by recall D-1034-2022 from Mckesson Medical-Surgical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.