NDC 0338-5197
Famotidine 20 mg per 50 mL injection, solution
On the label: Baxter Healthcare Corporation.
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Baxter Healthcare Corporation | Round Lake, IL, United States | Makes it, tests it, packages it, labels it and sterilizes it | Serious problems, FDA actionApr 2, 2026 · 15 inspections, 2 with FDA action |
Recalls
- Aug 6, 2026 · Class II · Baxter Healthcare Corporation
CGMP Deviations
Lots: Lot # NC188586, Exp Date: 02/28/2027; Lot # NC188913, Exp Date: 3/9/2027. - Apr 24, 2014 · Class II · Baxter Healthcare Corp.
Presence of Particulate Matter: Baxter Healthcare Corporation has received a complaint reporting the presence of particulate matter identified as plastic/rubber in famotidine Injection premixed containers.
Lots: Lot #: NC082768, Exp 12/23/2014
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Famotidine: every company that makes it
- Form
- injection, solution, intravenous
- Strength
- 20 mg per 50 mL
- Approval
- ANDA ANDA075591
- On the market since
- May 10, 2001
- Package NDCs
0338-5197-41- Official label
- DailyMed (National Library of Medicine), updated Aug 20, 2024
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