Class III · Low risk
Eligard (leuprolide acetate)
Superpotent Drug - Higher than expected levels of leuprolide acetate in the constituted product.
Lupron Depot (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 (Leuprolide Acetate for Depot Suspension) Single Dose Administration Kit with prefilled dual-chamber syringe, 22.5 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 0074-3346-03, UPC 3 00743 34603 9.
Affected NDC
0074-3346-03
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 leuprolide acetate NDC 00074-3346 |
Kit | AbbVie Inc. | Rx |
- Recalling firm
- AbbVie Inc
- NDC code
- 0074-3346-03
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1287-2014 · 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-Ped
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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