AbbVie Inc initiated a recall of Lupron Depot (leuprolide acetate for depot suspension) on March 10, 2014. The recall affects the Single Dose Administration Kit with prefilled dual-chamber syringe, 22.5 mg for 3-month administration, NDC 0074-3346-03.
The FDA classified this action as a Class II recall. The stated reason 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, based in North Chicago, Illinois, and manufactured by Takeda Pharmaceutical Company Limited in Osaka, Japan. Leuprolide remains an approved compound.
According to the event record, this recall action has a status of terminated. The recall reason concerns the delivery device component rather than the drug substance itself. No additional details regarding patient outcomes were included in this record.
Readers can consult the compound overview for more context on leuprolide.