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
- Dec 21, 2018 · Class II · Lupin Somerset
Subpotent Drug: Expansion of June 2018 recall of lots S700065 and S700619 due to below specification results for assay.
Lots: Lot #: S700038, S700044, S700059, S700065, Exp 28-Feb-19; S700410, S700427, Exp 30-Jun-19; S700617, S700619, Exp 31-Aug-19; S700813, S700815, S700869, Exp 31-Oct-19; S700871, S700873, Exp 30-Nov-19; S700875, S701073, Exp 31-Dec-19. - Jun 28, 2018 · Class II · Lupin Somerset
Subpotent Drug and Failed Content Uniformity.
Lots: Lot#: S700065, Exp. 02/2019; 700619, Exp. 08/2019
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Nitrofurantoin: every company that makes it
- Form
- suspension, oral
- Strength
- 25 mg per 5 mL
- Approval
- ANDA ANDA201693
- On the market since
- May 21, 2015
- Package NDCs
43386-450-11- Official label
- DailyMed (National Library of Medicine), updated Jun 2, 2022
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