Firmagon Injection Recalled Due to Manufacturing Temperature Abuse
McKesson Medical-Surgical is recalling 25 kits of Firmagon (degarelix for injection) 80 mg nationwide due to temperature abuse during manufacturing. No illnesses have been reported.
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 for cGMP manufacturing deviation involving temperature abuse. No illnesses or injuries have been reported, and the hazard is theoretical rather than confirmed, placing this at High severity per the rubric.
Plain-English summary
McKesson Medical-Surgical Inc. is recalling Firmagon (degarelix for injection) 80 mg maintenance dose kits from distribution. The recalled product is manufactured by Ferring Pharmaceuticals Inc. with NDC 55566-8303-01. A total of 25 kits have been distributed nationwide in the USA.
The recall was initiated due to a cGMP (current Good Manufacturing Practice) deviation. Specifically, the product was exposed to temperature abuse, which could potentially affect the quality and integrity of the medication.
The affected product was distributed nationwide. Patients and healthcare providers who may have used this product should not use remaining supplies and should consult with their healthcare provider regarding alternative treatment options.
The recalling firm is unable to identify specific lot numbers per customer. Each notification letter includes the distribution date and the dates when impacted product may have been shipped to the customer.
The recalled product
- Product
- Firmagon (degarelix for injection) 80 mg, Maintenance Dose (28 days), packaged in a kit, Rx only, MFG: Ferring Pharmaceuticals Inc., NDC 55566-8303-01
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug
- Hazard
- temperature-abuse
Distribution
Distributed nationwide across the United States.
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