The Recall Desk
ModerateFDA (Drugs)·D-0437-2017·Announced 2017-02-01

Roxane Recalls Furosemide Tablets Due to Unusually Thick Tablet Report

Roxane Laboratories is recalling 6,493 bottles of Furosemide 20 mg tablets because a complaint reported an unusually thick tablet.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a physical defect (unusually thick tablet) without reporting any illnesses or injuries, fitting the criteria for a moderate severity recall.

Plain-English summary

Roxane Laboratories, Inc. is recalling 6,493 bottles of Furosemide Tablets USP, 20 mg, 1000 count bottles. The product is identified by NDC 0054-4297-31, Lot# 660833A, and an expiration date of 08/31/18. The recall was initiated after a complaint reported an unusually thick tablet.

The affected product was distributed nationwide in the USA. Furosemide is a prescription-only medication used for increased diuresis at the loop of Henle. The recall is classified as Class II by the FDA.

Consumers with this product should stop using it and contact their healthcare provider or pharmacist for guidance on how to proceed.

The recalled product

Product
FUROSEMIDE (FUROSEMIDE)
Brand
FUROSEMIDE
Manufacturer
Roxane Laboratories, Inc.
Category
Drug — Prescription Drug
Hazard
Affected units
6,493

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot# 660833A
  • Exp 08/31/18

UPCs (4)

  • 0300544301251
  • 0300544299251
  • 0300544297257
  • 0300543298637

Distribution

Distributed nationwide across the United States.

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