Recalls / Class II
Class IID-1289-2014
Product
LUPRON DEPOT-PED (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 0074-3779-03, UPC 3 00743 77903 5.
- Brand name
- Lupron Depot-ped
- Generic name
- Leuprolide Acetate
- NDCs
- 0074-2108, 0074-2282, 0074-2440, 0074-3779, 0074-9694, 0074-3575
- FDA application
- NDA020263
- Affected lot / code info
- Lot #:1013566, Exp 12/08/16
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
- 12 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-1289-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.