Mckesson recalls 25 vial packages of 0.5% bupivacaine hydrochloride due to temperature abuse risks. This prescription drug may be unsafe if stored improperly.
cGMP deviations: Temperature abuse
Mckesson is recalling prescription bupivacaine hydrochloride injections because of temperature abuse risks. This could lead to unsafe drug conditions if stored incorrectly.
The product was manufactured with cGMP deviations related to temperature abuse. This means the drug could be unstable if stored outside recommended temperature ranges, potentially causing safety issues.
Prescription patients who received this specific bupivacaine product from Mckesson. Healthcare providers using this product for medical procedures are most at risk.
Check for the product name 'Bupivacaine Hydrochloride, USP 0.5% (5mg/mL), 25 vials x 50 mL per box' with NDC 0409-1163-01. This product was distributed by Mckesson Medical-Surgical and is prescription-only.
Identify the product by checking the NDC code 0409-1163-01 and the specific packaging description.
The recall indicates potential temperature abuse risks, but the product may still be safe if stored correctly. The manufacturer cannot identify specific affected lots.
Look for the NDC code 0409-1163-01 on the packaging of 25 vials of 0.5% bupivacaine hydrochloride.
The recall does not specify a remedy, so check with your healthcare provider or pharmacist for guidance.
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-1095-2022 — Mckesson Medical-Surgical Mckesson Medical-Surgical Hello, I own a Mckesson Medical-Surgical that is covered by recall D-1095-2022 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.
