NDC 68094-867
Furosemide 40 mg per 5 mL solution
On the label: Precision Dose Inc.. It's repackaged: Precision Dose Inc. rebottles it from Hikma Pharmaceuticals USA Inc.'s NDC 0054-3298.
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 |
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
- solution, oral
- Strength
- 40 mg per 5 mL
- Approval
- ANDA ANDA070433
- On the market since
- Jan 28, 2016
- Package NDCs
68094-867-5968094-867-62- Official label
- DailyMed (National Library of Medicine), updated Jun 13, 2024
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