FDA Drug recall D-1288-2014
Lupron Depot (Leuprolide Acetate for Depot Suspension) Single Dose Administration Kit with prefilled dual-chamber syringe, 45 mg for 6-mont…
- FDA Drug
- Class II
- terminated
- Published 2014-05-07
On 2014-05-07 the FDA classified a Class II recall of Lupron Depot (Leuprolide Acetate for Depot Suspension) Single Dose Administration Kit with prefilled dual-chamber syringe, 45 mg for 6-mont… by Abbvie, citing defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective LuproLoc needle stick protection device.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1288-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-03-10 |
| Published | 2014-05-07 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Abbvie |
| Distribution | US |
Product
Lupron Depot (Leuprolide Acetate for Depot Suspension) Single Dose Administration Kit with prefilled dual-chamber syringe, 45 mg for 6-month administration, Rx only, Manufactured for: AbbVie Inc., North Chicago, IL 60064; by: Takeda Pharmaceutical Company Limited, Osaka, Japan 540-8645; NDC 0074-3473-03, UPC 3 00743 47303 2.
Reason
Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective LuproLoc needle stick protection device.
Identifiers
| upc | 300743473032 |
|---|---|
| ndc | 0074-3473-03 |
| ndc | 0074-3473-55 |
| ndc | 0074-9945-01 |
| ndc | 0074-0009-01 |
| ndc | 0074-3683-03 |
| ndc | 0074-3683-55 |
| ndc | 0074-9930-01 |
| ndc | 0074-3642-03 |
| ndc | 0074-3642-55 |
| ndc | 0074-9907-01 |
| ndc | 0074-3346-03 |
| ndc | 0074-3346-55 |
| ndc | 0074-9922-01 |
| code_info | Lot # 1013976, Exp 09/25/15 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1288-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.