NDC 0517-0032
Cyanocobalamin 1000 ug per 1 mL injection, solution
On the label: American Regent, Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| American Regent, Inc. | Shirley, NY, United States | Makes it and tests it | Problems found, fixed voluntarilyApr 24, 2024 · 12 inspections, 1 with FDA action |
Recalls
- Jul 24, 2026 · Class II · American Regent, Inc.
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Lots: Lot #: 24297, Exp. Date 8/31/2026; 24364, Exp. Date: 10/31/2026; - Jul 24, 2026 · Class II · American Regent, Inc.
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Lots: Lot #: 25082, Exp. Date: 3/31/2027.
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 ANDA080737
- On the market since
- Nov 7, 1996
- Package NDCs
0517-0032-010517-0032-25- Official label
- DailyMed (National Library of Medicine), updated Oct 31, 2023
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