AbbVie Inc initiated a recall of Lupron Depot-PED on March 10, 2014. The action affects the Leuprolide Acetate for Depot Suspension Single Dose Administration Kit, 11.25 mg for 3-month administration, manufactured by Takeda Pharmaceutical Company Limited for AbbVie.
The FDA classified this recall as Class II. 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 affected product is identified as NDC 0074-3779-03, UPC 3 00743 77903 5, a prefilled dual-chamber syringe kit available by prescription only. The recall record lists the status as terminated.
This recall applies specifically to the pediatric depot kit noted above and reflects the reported device issue as documented by regulatory records. No additional details about patient outcomes were included in the event data.
For broader context on leuprolide, its approved uses, and formulation, readers can consult the compound overview.