Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Fresenius Kabi USA, LLC | Grand Island, NY, United States | Makes it and tests it | Problems found, fixed voluntarilyOct 13, 2023 · 14 inspections, 2 with FDA action |
Recalls
- Nov 15, 2018 · Class I · Fresenius Kabi USA, LLC
Labeling Not Elsewhere Classified: Fresenius Kabi is taking this action due to an incorrect statement on the product insert for product codes 918610 and 918620 indicating that the stoppers do not contain natural rubber latex. The tray label for these two product codes and the vial label for product code 918620 also incorrectly state that the stoppers do not contain latex. The above listed product codes and batches being recalled have stoppers containing natural rubber latex.
Lots: Lot# EXP date: 6013112 11/2018 6013113 11/2018 6013114 11/2018 6013180 11/2018 6013181 11/2018 6013182 11/2018 6013237 01/2019 6013238 01/2019 6013239 01/2019 6013468 02/2019 6013512 02/2019 6013513 02/2019 6013551 02/2019 6013552 02/2019 6013553 02/2019 6013607 02/2019 601… - Nov 15, 2018 · Class I · Fresenius Kabi USA, LLC
Labeling Not Elsewhere Classified: Fresenius Kabi is taking this action due to an incorrect statement on the product insert for product codes 918610 and 918620 indicating that the stoppers do not contain natural rubber latex. The tray label for these two product codes and the vial label for product code 918620 also incorrectly state that the stoppers do not contain latex. The above listed product codes and batches being recalled have stoppers containing natural rubber latex.
Lots: Lot# EXP date: 6013062 11/2018 6014162 05/2019 6014163 05/2019 6014164 05/2019 6014377 06/2019 6014378 06/2019 6014379 06/2019 6016005 02/2020 6016071 02/2020 6016072 02/2020 6016073 02/2020 6017383 07/2020 6017384 07/2020 6017422 07/2020 6017423 07/2020 6017424 07/2020
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Sodium Cation: every company that makes it
- Form
- injection, intravenous
- Strength
- 9 mg per 1 mL
- Approval
- ANDA ANDA088912
- On the market since
- Aug 10, 2000
- Package NDCs
63323-186-0163323-186-0263323-186-0363323-186-0463323-186-1063323-186-20- Official label
- DailyMed (National Library of Medicine), updated Feb 10, 2022
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