Recalls / Class II
Class IID-1288-2014
Product
Lupron Depot (Leuprolide Acetate for Depot Suspension) Single Dose Administration Kit with prefilled dual-chamber syringe, 45 mg for 6-month administration, Rx only, Manufactured for: AbbVie Inc., North Chicago, IL 60064; by: Takeda Pharmaceutical Company Limited, Osaka, Japan 540-8645; NDC 0074-3473-03, UPC 3 00743 47303 2.
- Brand name
- Lupron Depot
- Generic name
- Leuprolide Acetate
- NDCs
- 0074-3346, 0074-3473, 0074-3683, 0074-3642
- FDA application
- NDA020517
- Affected lot / code info
- Lot # 1013976, Exp 09/25/15
Why it was recalled
Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective LuproLoc needle stick protection device.
Recalling firm
- Firm
- AbbVie Inc
- Manufacturer
- AbbVie Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 N Waukegan Rd, North Chicago, Illinois 60064
Distribution
- Quantity
- 36 kits
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2014-03-10
- FDA classified
- 2014-04-29
- Posted by FDA
- 2014-05-07
- Terminated
- 2016-06-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1288-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.