TerSera Therapeutics LLC — Class II: Zoladex (goserelin) implant, 3.6 mg, One single-Use Syringe packaged in a carton, Rx only,
TerSera Therapeutics LLC initiated a Class II recall for Zoladex (goserelin) 3.6 mg implants due to temperature abuse occurring during distribution. A shipment was held in a non-temperature-controlled trailer for 25.5 hours under ambient outdoor conditions.
This recall affects TerSera Therapeutics LLC, AstraZeneca UK Limited, and supply chain professionals managing temperature-sensitive injectable implants.
Temperature excursions during transit represent a failure in the controlled distribution chain, potentially compromising the stability or efficacy of the implantable drug. The 25.5-hour duration suggests a significant breakdown in logistics oversight or carrier compliance, necessitating a Class II enforcement action to mitigate risks associated with sub-potent or degraded medication.
Ensure distribution partners have robust contingency plans for trailer storage and verify that environmental monitoring systems provide alerts for deviations. Review shipping validation studies to determine if existing stability data covers excursions of this duration and magnitude.
Class II. Reason: Temperature Abuse: Product sat in a non-temperature-controlled FedEx trailer at ambient outdoor conditions for 25.5 hours.. Product: Zoladex (goserelin) implant, 3.6 mg, One single-Use Syringe packaged in a carton, Rx only, Manufactured for: TerSera therapeutics LLC, Deerfield, IL 60015, BY: AstraZeneca UK Limited, Macclesfield, England, Product of Switzerland, website at www.zoladex.com, NDC 70720-950-36.. Firm: TerSera Therapeutics LLC (Deerfield IL United States). Status: Ongoing.
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