D-1290-2014 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
- 1,530 kits
Product Description
Lupron Depot (leuprolide acetate for depot suspension) Single Dose Administration Kit with prefilled dual-chamber syringe, 11.25 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 0074-3663-03, UPC 3 00743 66303 7.
Reason for Recall
Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective LuproLoc needle stick protection device.
Distribution Pattern
Nationwide and Puerto Rico
Code Information
Lot #: 1013906, Exp 09/21/16