The Recall Desk
HighFDA (Drugs)·D-1016-2022·Announced 2022-06-15

Firmagon Degarelix Injection Recalled for Temperature Abuse During Distribution

McKesson Medical-Surgical is recalling 15 boxes of Firmagon degarelix injection due to temperature abuse during distribution. The temperature exposure may compromise the pharmaceutical's stability and safety.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The manufacturing defect (temperature abuse) presents potential risk to drug efficacy without confirmed patient harm, meeting criteria for High severity.

Plain-English summary

McKesson Medical-Surgical Inc. is recalling 15 boxes of Firmagon (degarelix for injection) 240 mg due to a manufacturing quality deviation involving temperature abuse during storage and distribution. The temperature exposure may affect the pharmaceutical's stability and safety.

Patients and healthcare providers should not use the recalled product. Contact your pharmacist or healthcare provider immediately if you have received this medication for guidance on next steps. Do not discontinue therapy without consulting your healthcare provider first.

The recalled product was distributed nationwide in the United States. McKesson Medical-Surgical was unable to identify specific lot numbers that reached individual patients based on their records. Recall notices have been sent to customers who received the affected shipments.

The recalled product

Product
Firmagon (degarelix for injection) 240 mg, Starting Dose, packaged in a kit, Rx only, MFG: Ferring Pharmaceuticals Inc., NDC 55566-8403-01
Manufacturer
Mckesson Medical-Surgical Inc. Corporate Office
Category
Drug — Injectable / Prescription
Hazard
  • temperature-abuse
  • manufacturing-defect

Distribution

Distributed nationwide across the United States.

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