CLASS II Drug recall · Reported 7 May 2014 · FDA Enforcement Report
Lupron Depot-ped (Leuprolide Acetate recalled by AbbVie
AbbVie is recalling Lupron Depot-ped (Leuprolide Acetate for Depot Suspension) Single Dose Administration Kit, distributed nationwide in the US. The recall was initiated on 10 Mar 2014 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1289-2014
- FDA event ID
- 67709
- Recalling firm
- AbbVie, North Chicago, IL
- Brand
- Lupron Depot-ped
- Manufacturer
- AbbVie Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Mar 2014
- FDA classified
- 29 Apr 2014
- Reported
- 7 May 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
Timeline
| 10 Mar 2014 | Recall initiated by company | |
| 29 Apr 2014 | Classified by FDA | +50 days |
| 7 May 2014 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective LuproLoc needle stick protection device.
Product as listed by the FDA
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.
Where it was distributed
Nationwide and Puerto Rico
Questions about this recall
Is Lupron Depot-ped (Leuprolide Acetate for Depot Suspension) Single Dose Administration Kit recalled?
Yes. AbbVie recalled Lupron Depot-ped (Leuprolide Acetate for Depot Suspension) Single Dose Administration Kit on 10 Mar 2014. The recall is Class II and its status is Terminated. Recall number D-1289-2014.
Why was it recalled?
Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective LuproLoc needle stick protection device.
Which lots are affected?
Lot #:1013566, Exp 12/08/16
Where was it sold?
Nationwide and Puerto Rico
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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