Furosemide Tablets USP, 20 mg, 1000 count bottles, Rx only, Roxane Laboratories, Inc., Columbus, ...
FDA Recall #D-0437-2017 — Class II — December 22, 2016
Product Description
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.
Recalling Firm
Roxane Laboratories, Inc. — Columbus, OH
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
6493 bottles
Distribution
Nationwide in the USA
Code Information
Lot# 660833A, Exp 08/31/18
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated