Mckesson recalls BENLYSTA 400 mg/20 mL vials (NDC 49401-102-01) due to potential temperature excursions during transit. This may affect drug stability.
CGMP Deviations; potential temperature excursions due to transit delays
Mckesson is recalling BENLYSTA 400 mg/20 mL vials (NDC 49401-102-01) because temperature issues during shipping could affect drug stability. This recall does not pose an immediate risk to patients but requires proper handling to maintain safety.
The recall is for potential temperature excursions during transit, which could affect the drug's stability. This means the medication might not be safe for use if it was exposed to temperatures outside the required range during shipping.
Patients prescribed BENLYSTA 400 mg/20 mL vials (NDC 49401-102-01) by a doctor. Healthcare providers handling the product are most at risk due to potential stability issues.
Check for BENLYSTA 400 mg/20 mL vials with NDC 49401-102-01. The lot number is YK4W and expiration date is April 30, 2029.
Verify the NDC code 49401-102-01 and lot number YK4W on the vial.
The recall is due to potential temperature issues during transit, but the product is safe if handled properly. Patients should not use it if they suspect temperature exposure.
The recall record does not specify a replacement process or remedy.
The recall record does not provide specific instructions for disposal or return.
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-0540-2025 — Mckesson Medical-Surgical Mckesson Medical-Surgical Hello, I own a Mckesson Medical-Surgical that is covered by recall D-0540-2025 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.