Drug product
Lupron Depot (Leuprolide Acetate for Depot Suspension) Single Dose Administration Kit with prefilled dual-chamber syringe, 22.5 mg for 3-month administration, Rx only, Manufactured for: AbbVie Inc., North Chicago, IL 60064; by: Takeda Pharmaceutical Company Limited, Osaka, Japan 540-8645; NDC 0074-3346-03, UPC 3 00743 34603 9.
D-1287-2014
Product summary
- Firm
- AbbVie Inc
- Event
- Event 67709
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7362 kits
- Official record key
drug-enforcement:D-1287-2014
Official wording
Reason: Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective LuproLoc needle stick protection device.
Code information: Lot #: 1014204, Exp 10/11/15; 1014485, Exp 12/11/16; and 1015007, Exp 12/06/16
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Unknown
Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective LuproLoc needle stick protection device.