NDC 76420-111
Cyanocobalamin 1000 ug per 1 mL injection, solution
On the label: Asclemed USA, Inc.. It's repackaged: Asclemed USA, Inc. rebottles it from Fresenius Kabi, LLC's NDC 63323-044.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Fresenius Kabi USA, LLC | Melrose Park, IL, United States | Makes it and tests it | Problems found, fixed voluntarilyAug 24, 2023 · 13 inspections, 2 with FDA action |
Repackaging site
- Asclemed USA Inc. dba Enovachem, Torrance, CA, United States · relabels it
Recalls
- Sep 27, 2012 · Class II · Fresenius Kabi USA, LLC
Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles.
Lots: Lot 6003853, exp. date 04/2014
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Cyanocobalamin: every company that makes it
- Form
- injection, solution, intramuscular; subcutaneous
- Strength
- 1000 ug per 1 mL
- Approval
- ANDA ANDA080557
- On the market since
- Oct 18, 2000
- Package NDCs
76420-111-25- Official label
- DailyMed (National Library of Medicine), updated Jul 8, 2021
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