Eli Lilly & Co
FDA Regulatory Profile
Summary
- Total Recalls
- 5 (1 Class I)
- 510(k) Clearances
- 7
- Inspections
- 36
- Compliance Actions
- 3
Known Names
eli lilly and, eli lilly and company
Recent Recalls
| Number | Class | Product | Date |
|---|
| D-0445-2024 | Class II | Sterile Diluent, HUMALOG U-100 (insulin lispro injection), HUMULIN R U-100 REGULAR (insulin human in | March 12, 2024 |
| D-0009-2022 | Class I | Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection, 1 mg per vial; Diluent for Gluca | September 24, 2021 |
| D-0773-2021 | Class II | Trulicity (dulaglutide), 0.75 mg/0.5 mL, 4 Single-Dose Pens per box, Rx only, Eli Lilly and Company, | August 19, 2021 |
| D-0720-2021 | Class II | Zyprexa Intramuscular, Olanzapine for Injection, 10 MG per Single Use Vial, Rx only, Marketed by: Li | June 29, 2021 |
| D-0248-2019 | Class III | ERBITUX CETUXIMAB Injection, 200 mg/100 mL (2 mg/mL), 100 mL per single-use vial, Rx only, Manufactu | November 8, 2018 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K212217 | Tempo Smart Button | September 16, 2022 |
| K160949 | Go Dose System | December 22, 2016 |
| K142518 | HumaPen Luxura | June 5, 2015 |
| K100988 | HUMAPEN LUXURA HD | August 17, 2010 |
| K063151 | HUMAPEN LUXURA HD | January 9, 2007 |
| K053563 | HUMAPEN MEMOIR | April 7, 2006 |
| K982842 | HUMAPEN AND HUMAPEN ERGO | September 25, 1998 |