Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Novel Laboratories, Inc. | Somerset, NJ, United States | Makes it, tests it and packages it | Problems found, fixed voluntarilyApr 17, 2026 · 15 inspections, 1 with FDA action |
Recalls
- Jun 20, 2014 · Class III · Novel Laboratories, Inc.
Failed Impurity/Degradation Specification; 12-month stability time point
Lots: Lot #'s M13075A, M13076A, M13076B, M13077A, M13077B all with expiry dated 2/2015 and M13490A with expiry date 3/2016.
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
- for suspension, oral
- Strength
- 40 mg per 5 mL
- Approval
- ANDA ANDA201695
- On the market since
- Dec 17, 2012
- Package NDCs
43386-500-11- Official label
- DailyMed (National Library of Medicine), updated Nov 21, 2017
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