Mckesson Medical-Surgical recalls Intralipid 20% 100mL IV fat emulsions (Rx only) manufactured by Baxter Healthcare due to temperature abuse risks. This recall addresses potential cGMP deviations affecting product safety.
cGMP deviations: Temperature abuse
Mckesson Medical-Surgical has recalled Intralipid 20% 100mL IV fat emulsion bags (Rx only) because of temperature abuse risks. This could lead to product instability and potential safety issues for patients receiving intravenous treatments.
The product was manufactured with cGMP deviations related to temperature abuse. This means the product may have been exposed to temperatures that could cause instability, potentially leading to safety issues during medical use.
Healthcare providers and patients who have received this specific IV fat emulsion product from Mckesson Medical-Surgical. Those using the product for medical treatments are most at risk.
Check for Intralipid 20% 100mL IV fat emulsion bags (Rx only) with NDC 0338-0519-58 manufactured by Baxter Healthcare. The recall covers products distributed by Mckesson Medical-Surgical without specific lot numbers identified for each customer.
Identify the product by checking the NDC code 0338-0519-58 and manufacturer Baxter Healthcare on the IV bag.
The recall is due to cGMP deviations related to temperature abuse, which could affect product stability.
Check for Intralipid 20% 100mL IV fat emulsion bags with NDC 0338-0519-58 manufactured by Baxter Healthcare.
The official notice does not specify a remedy for this recall, so no action is required beyond checking product details.
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-1120-2022 — Mckesson Medical-Surgical Mckesson Medical-Surgical Hello, I own a Mckesson Medical-Surgical that is covered by recall D-1120-2022 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.
