On March 10, 2014, a Class II recall was initiated for Lupron Depot (leuprolide acetate for depot suspension) Single Dose Administration Kits. The affected product is the 11.25 mg kit for 3-Month administration, packaged with a prefilled dual-chamber syringe, NDC 0074-3663-03.
The recall reason cited is a defective delivery system. Some Lupron Depot Kits may contain 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. The FDA classified this action as Class II. The recall status is listed as terminated.
This recall pertains specifically to the administration kit's needle protection device, as described in the FDA record. No additional details about patient outcomes or further findings were included in this event record.
Readers can consult the compound overview for more context on leuprolide.