Mckesson Medical-Surgical recalls Firmagon (degare: 80mg maintenance dose kits) due to temperature abuse risks. Products may have been shipped without proper temperature control.
cGMP deviations: Temperature abuse
Mckesson Medical-Surgical is recalling Firmagon (degarelix for injection) 80 mg maintenance dose kits because they may have been exposed to improper temperatures. This could lead to product instability and potential safety issues for patients using the medication.
The recall is due to cGMP deviations related to temperature abuse. This means the medication may have been stored or transported outside the required temperature range, potentially causing the product to become unstable or ineffective.
Prescription patients using Firmagon 80 mg maintenance dose kits from Mckesson Medical-Surgical. Healthcare providers who dispensed these kits are most at risk of handling compromised products.
Check for Firmagon (degarelix for injection) 80 mg maintenance dose kits with NDC 55566-8303-01. Products were distributed by Mckesson Medical-Surgical and may have been shipped without proper temperature control.
Identify if you have Firmagon 80 mg maintenance dose kits with NDC 55566-8303-01.
The product was recalled due to cGMP deviations related to temperature abuse, meaning it may have been stored or transported outside the required temperature range.
Check for Firmagon (degarelix for injection) 80 mg maintenance dose kits with NDC 55566-8303-01. Products were distributed by Mckesson Medical-Surgical and may have been shipped without proper temperature control.
The recall does not specify a remedy, so contact your healthcare provider or pharmacist for guidance on next steps.
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-1015-2022 — Mckesson Medical-Surgical Mckesson Medical-Surgical Hello, I own a Mckesson Medical-Surgical that is covered by recall D-1015-2022 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.