Insulin Analog
Where is Insulin Aspart made?
5 companies sell it under their own name and 5 repackagers rebottle it. Their labels name 3 factories in Malaysia, China and Germany.
Malaysia 1China 1Germany 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Biocon Biologics Inc. Kirsty100 [iU] per 1 mL · NDC 83257-007, 83257-008 | Biocon Sdn.bhd.Makes it, tests it and packages it | Iskander Puteri, Malaysia | Problems found, fixed voluntarilySep 2024 |
| Meitheal Pharmaceuticals Inc. Garzulys100 [iU] per 1 mL · NDC 71288-904, 71288-903 | Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd (API and FDF Site)Makes it | Nanjing, China | Problems found, fixed voluntarilyNov 2023 |
| Sanofi-Aventis U.S. LLC Merilog100 [iU] per 1 mL · NDC 0024-5927, 0024-5928 | Sanofi-Aventis Deutschland GmbHMakes it, makes the active ingredient, packages it and labels it | Frankfurt am Main, Germany | Problems found, fixed voluntarilyMar 2022 |
| Novo Nordisk Fiasp, Novolog, NovoLog Mix 70/30100 [iU] per 1 mL · NDC 0169-3201, 0169-3204, 0169-3205 +11 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Novo Nordisk Pharma, Inc. Insulin Aspart Protamine and Insulin AspartMix 70/30100 [iU] per 1 mL · NDC 73070-100, 73070-102, 73070-103 +2 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Insulin Aspart 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:
50090-1664,50090-1665,50090-1678,50090-4500+5 - Dispensing Solutions Inc.:
68258-8899 - Physicians Total Care, Inc.:
54868-5201,54868-5327 - Remedyrepack Inc.:
70518-2119,70518-3865,70518-3236 - TYA Pharmaceuticals:
64725-0750
Recalls
- Mar 22, 2021 · Class I · Novo Nordisk Inc · 5 recall notices
Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.