A Class II recall of Lupron Depot, containing leuprolide acetate, was initiated on March 10, 2014. The recall affected the Single Dose Administration Kit with prefilled dual-chamber syringe, 22.5 mg for 3-month administration, NDC 0074-3346-03.
The reason cited was a defective delivery system. Some Lupron Depot Kits may have contained a syringe with a potentially defective LuproLoc needle stick protection device.
The product was manufactured for AbbVie Inc. of North Chicago, Illinois, by Takeda Pharmaceutical Company Limited of Osaka, Japan. AbbVie Inc is listed as the recalling firm.
This action was classified as Class II by the FDA. The recall status is listed as terminated. The FDA recall identification number for this action is D-1287-2014.
This recall pertains specifically to the delivery device component of the kit as described in the official reason statement. No additional details beyond the classification, reason, firm, and dates were provided in this record.
Readers can consult the leuprolide compound overview for further context on this medication.