NDC 43353-069
Furosemide 40 mg tablet
On the label: Aphena Pharma Solutions - Tennessee, Inc.. It's repackaged: Aphena Pharma Solutions - Tennessee, Inc. rebottles it from Hikma Pharmaceuticals USA Inc.'s NDC 0054-4299.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| West-Ward Columbus Inc. | Columbus, OH, United States | Makes it | No problems foundApr 30, 2026 · 27 inspections |
Repackaging site
- Aphena Pharma Solutions - Tennessee, LLC, Cookeville, TN, United States · repackages it
Recalls
- Dec 22, 2016 · Class II · Roxane Laboratories, Inc.
Failed Tablet/Capsule Specifications: An unusually thick tablet was reported through a complaint.
Lots: Lot# 660833A, Exp 08/31/18 - Sep 25, 2015 · Class III · Boehringer Ingelheim Roxane Inc
CGMP Deviations: The active pharmaceutical ingredient (API) intended for use in furosemide oral solution USP was inadvertently used to manufacture the recalled furosemide tablets USP.
Lots: Lot #: 559660P, 559661P, Exp 03/17 - Sep 25, 2015 · Class III · Boehringer Ingelheim Roxane Inc
CGMP Deviations: The active pharmaceutical ingredient (API) intended for use in furosemide oral solution USP was inadvertently used to manufacture the recalled furosemide tablets USP.
Lots: Lot #: 559310P, Exp 02/17; 559664B, Exp 04/17
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Furosemide: every company that makes it
- Form
- tablet, oral
- Strength
- 40 mg
- Approval
- NDA NDA018823
- On the market since
- Nov 10, 1983
- Package NDCs
43353-069-3043353-069-4543353-069-5343353-069-6043353-069-80- Official label
- DailyMed (National Library of Medicine), updated Feb 9, 2018
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