Class III · Low risk
Eligard (leuprolide acetate)
Superpotent Drug - Higher than expected levels of leuprolide acetate in the constituted product.
Lupron Depot-Ped (Leuprolide Acetate)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective LuproLoc needle stick protection device.
Cause type: Packaging defect
Failed child-resistant closures, leaks, cracked containers, or a defective delivery device. Packaging failures risk accidental exposure (especially to children) or product contamination. All packaging defect recalls.
What was recalled
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.
Affected NDC
0074-3779-03
Compare with the code on your package — it is the most precise check available.
Drug: Leuprolide
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Lupron Depot-PED leuprolide acetate NDC 00074-3779 |
Kit | AbbVie Inc. | Rx |
- Recalling firm
- AbbVie Inc
- NDC code
- 0074-3779-03
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1289-2014 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Leuprolide recalls
See all
Class II · Moderate risk
Leuprolide 50 mcg/0.1 mL Micro Lupron Kit
Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Class II · Moderate risk
Lupron Depot
Defective Delivery System: Some Lupron Depot Kits may containin a syringe with a potentially defective LuproLoc needle stick protection device.
Class II · Moderate risk
Lupron Depot
Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective LuproLoc needle stick protection device.
Class II · Moderate risk
Lupron Depot
Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective LuproLoc needle stick protection device.
Other recalls by AbbVie Inc
All 2014 recalls
Class III · Low risk
Pred Mild
Failed Stability Specifications
Class II · Moderate risk
Refresh LACRI-LUBE
Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.
Class II · Moderate risk
Refresh P.M.
Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.
Class III · Low risk
Synthroid
Labeling: Wrong Barcode- One (1) of every forty (40) unit dose blister will contain incorrect barcode information that causes a 125mcg unit dose is scanned as 200mcg unit dose.
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