D-1291-2014 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- May 7, 2014
- Initiation Date
- March 10, 2014
- Termination Date
- June 22, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2915 kits
Product Description
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.
Reason for Recall
Defective Delivery System: Some Lupron Depot Kits may containin a syringe with a potentially defective LuproLoc needle stick protection device.
Distribution Pattern
Nationwide and Puerto Rico
Code Information
Lot #: 1012381, 1012383, Exp 08/22/16