Furosemide Tablets USP, 20 mg, 1000 count bottles, Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-4297-31.

FDA recall notice · announced February 1, 2017 · Roxane Laboratories

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Furosemide Tablets USP, 20 mg, 1000 count bottles, Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-4297-31.

Reason for recall

Failed Tablet/Capsule Specifications: An unusually thick tablet was reported through a complaint.

Notes

Distribution: Nationwide in the USA
Lot/code information: Lot# 660833A, Exp 08/31/18
Quantity: 6493 bottles
Status: Terminated
Products in this recall event:
- Furosemide Tablets USP, 20 mg, 1000 count bottles, Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-4297-31. (D-0437-2017)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.