Why it was recalled
Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective LuproLoc needle stick protection device.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot #:1013566, Exp 12/08/16
Where it was sold
Nationwide and Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1289-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 10, 2014
- FDA report date
- May 7, 2014
- Quantity
- 12 kits
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- AbbVie Inc
Original FDA data
Every field from FDA enforcement report D-1289-2014, exactly as published.
Show all FDA fields
- City
- North Chicago
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 67709
- Address
- 1 N Waukegan Rd
- Code information
- Lot #:1013566, Exp 12/08/16
- Postal code
- 60064
- Report date
- May 7, 2014
- Product type
- Drugs
- Recall number
- D-1289-2014
- Classification
- Class II
- Recalling firm
- AbbVie Inc
- Product quantity
- 12 kits
- Termination date
- Jun 22, 2016
- Reason for recall
- Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective LuproLoc needle stick protection device.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Mar 10, 2014
- Initial firm notification
- Letter
- Center classification date
- Apr 29, 2014