A Class II recall of Lupron Depot (Leuprolide Acetate for Depot Suspension) was initiated on March 10, 2014. The recall affects the Single Dose Administration Kit with prefilled dual-chamber syringe, 7.5 mg for 1-month administration, NDC 0074-3642-03.
The recall was initiated by AbbVie Inc, with the product manufactured by Takeda Pharmaceutical Company Limited. The stated reason for the recall is a defective delivery system. According to the recall record, some Lupron Depot Kits may contain a syringe with a potentially defective LuproLoc needle stick protection device.
The FDA classified this action as Class II. The recall status is listed as terminated. No additional details about patient outcomes or adverse events are included in this record.
This information reflects only the details contained in the recall record as published. Readers seeking more background on leuprolide, including its approved uses and regulatory status, can consult the compound overview for additional context.