Insulin Analog
Where is Insulin Lispro made?
2 companies sell it under their own name and 4 repackagers rebottle it. Their labels name 1 factory in Germany.
Germany 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Sanofi-Aventis U.S. LLC Admelog100 U per 1 mL · NDC 0024-5924, 0024-5925, 0024-5926 | Sanofi-Aventis Deutschland GmbHMakes it, makes the active ingredient, tests it, packages it and labels it | Frankfurt am Main, Germany | Problems found, fixed voluntarilyMar 2022 |
| Eli Lilly and Company Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25 KwikPen, Insulin Lispro KwikPen, Insulin Lispro Junior KwikPen, Humalog Mix50/50 KwikPen, Lyumjev, LYUMJEV KwikPen, LYUMJEVJunior KwikPen, LYUMJEVTempo Pen, Humalog Mix75/25, Humalog Mix75/25 KwikPen, Humalog, HumalogKwikPen, Humalog Junior KwikPen, Humalog Tempo Pen100 [iU] per 1 mL, 200 [iU] per 1 mL · NDC 0002-8233, 0002-7737, 0002-8222 +17 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Insulin Lispro in bulk and rebottle it, often for mail-order, clinic or hospital pharmacies. If your bottle shows one of these names, open its NDC to see who made the pills inside.
- A-S Medication Solutions:
50090-4488,50090-4073,50090-1375,50090-1663+2 - Dispensing Solutions Inc.:
55045-3602 - Physicians Total Care, Inc.:
54868-4381,54868-5108,54868-5899,54868-5836 - Remedyrepack Inc.:
70518-4275
Recalls
- Mar 12, 2024 · Class II · Eli Lilly & Company
CGMP Deviations - Apr 11, 2023 · Class II · Sanofi-Aventis U.S. LLC
Lack of Assurance of Sterility: Malformed crimped collar seal - Apr 5, 2022 · Class I · Cardinal Health Inc.
TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions due to inclement weather. - Jul 5, 2018 · Class II · Sanofi-Aventis U.S. LLC
Temperature Abuse: Product samples of Admelog may not have been shipped at proper temperature.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.