Drug product
Lupron Depot (Leuprolide Acetate for Depot Suspension) Single Dose Administration Kit with prefilled dual-chamber syringe, 7.5 mg for 1-month administration, Rx only, Manufactured for: AbbVie Inc., North Chicago, IL 60064; by: Takeda Pharmaceutical Company Limited, Osaka, Japan 540-8645; NDC 0074-3642-03, UPC 3 00743 64203 2.
D-1291-2014
Product summary
- Firm
- AbbVie Inc
- Event
- Event 67709
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2915 kits
- Official record key
drug-enforcement:D-1291-2014
Official wording
Reason: Defective Delivery System: Some Lupron Depot Kits may containin a syringe with a potentially defective LuproLoc needle stick protection device.
Code information: Lot #: 1012381, 1012383, Exp 08/22/16
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Unknown
Defective Delivery System: Some Lupron Depot Kits may containin a syringe with a potentially defective LuproLoc needle stick protection device.