An outsourcing facility mislabeled enoxaparin syringes asphytonadione syringesand sent them out to multiple facilities. Which type of recall would be most appropriate to issue?
AClass I recallis themost seriousrecall issued when amedication labeling erroror contaminationcould result in serious harm or death.
Enoxaparin (Lovenox)is ananticoagulant, whilephytonadione (Vitamin K1)is anantidote for warfarin toxicity—confusing these could lead to life-threatening bleeding or clotting issues.
TheFDA mandates an immediate Class I recallfor errors that could causefatal outcomes.
Why Other Options Are Incorrect:
B. Class II?❌Used formoderate health risks(e.g., subpotent drugs).
C. Class III?❌Used forminor errors(e.g., misprinted labels, minor defects).
D. Misbranding?❌Misbranding is a regulatory issue butnot a recall classification.
????Reference:FDA Drug Recall Guidelines, ISMP Medication Safety Alerts.
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