Mckesson Medical-Surgical recalls PROLIA (denosumab) injections due to possible temperature excursions during shipping. Affected lots may have been exposed to unsafe temperatures.
CGMP Deviations; potential temperature excursions due to transit delays
Mckesson is recalling PROLIA (denosumab) injections that may have experienced temperature issues during shipping. This could affect the product's safety and effectiveness if the temperature was not properly controlled.
The product may have been exposed to unsafe temperatures during transit due to manufacturing deviations. This could potentially affect the product's stability and effectiveness, though serious injury risks are not described.
Prescription patients using PROLIA injections for bone density treatment. Healthcare providers who dispensed the recalled product may also be affected.
Check the product label for the NDC number 55513-710-21 and lot number 1180924. The expiration date is June 30, 2027. This product is only available by prescription.
Look for the NDC number 55513-710-21 and lot number 1180924 on the product label.
The recall indicates potential temperature issues during transit, but no specific safety risks are described. The product may still be safe if stored properly.
Check the product label for NDC 55513-710-21 and lot number 1180924. This product is only available by prescription.
The recall does not specify a remedy, so contact your healthcare provider or pharmacy 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-0538-2025 — Mckesson Medical-Surgical Mckesson Medical-Surgical Hello, I own a Mckesson Medical-Surgical that is covered by recall D-0538-2025 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.
