Fresenius Kabi USA, LLC — Class III: Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial, Rx only, Fresenius Kabi, Lake Z
Fresenius Kabi USA, LLC has initiated a Class III recall for Epinephrine Injection, USP, 1mg/mL (1 mL single-dose vials) due to failure to meet impurities and degradation specifications.
This recall affects Fresenius Kabi USA, LLC, as well as healthcare facilities, pharmacies, and distributors holding affected lots (NDC 63323-696-02 and 63323-696-25).
A Class III recall indicates that the product's failure to meet specifications is unlikely to cause adverse health consequences, but still represents a regulatory non-compliance. For pharmaceutical manufacturers, this highlights the necessity of maintaining rigorous stability profiles and suggests that degradation pathways for this epinephrine formulation may have exceeded established limits during the product's shelf life.
QA teams should verify stock for the specified NDC numbers (63323-696-02 and 63323-696-25) and ensure that stability testing protocols are robust enough to detect impurity trends before they exceed USP specifications. Verify that current storage conditions align with labeled requirements to mitigate degradation risks.
Class III. Reason: Failed Impurities/Degradations Specifications. Product: Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-696-02 (vial), NDC 63323-696-25 (carton). Firm: Fresenius Kabi USA, LLC (Lake Zurich IL United States). Status: Ongoing.
Open in openFDA / FDA.gov