Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Fresenius Kabi AB | Uppsala, Sweden | Makes it and tests it | Problems found, fixed voluntarilyJan 24, 2025 · 8 inspections |
Recalls
- Apr 13, 2022 · Class II · Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
Lots: McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer. - Apr 13, 2022 · Class II · Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
Lots: McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer. - Sep 15, 2017 · Class I · Baxter Healthcare Corporation
Temperature Abuse: A portion of this product lot was exposed to subfreezing temperatures, which is outside of the acceptable storage range listed on the product labeling, during transit to a distribution facility.
Lots: Lot #: 10LE9597, Exp 04/01/19
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Soybean Oil: every company that makes it
- Form
- emulsion, intravenous
- Strength
- 20 g per 100 mL
- Approval
- NDA NDA020248
- On the market since
- Apr 1, 2004
- Package NDCs
0338-0519-14- Official label
- DailyMed (National Library of Medicine), updated Jul 21, 2022
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