December 2016 FDA Recall Furosemide by Roxane Laboratories, Inc.
D-0437-2017 - Failed Tablet/Capsule Specifications
This Class II drug recall was voluntarily initiated by Roxane Laboratories, Inc. on December 22, 2016 for the product Furosemide. The FDA reported the reason for recall as failed tablet/capsule specifications. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0437-2017
Failed Tablet/Capsule Specifications: An unusually thick tablet was reported through a complaint.
12-22-2016
02-01-2017
6493 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Roxane Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA
12-18-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Furosemide Tablets USP, 20 mg, 1000 count bottles, Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-4297-31.
Batch or Lot Expiration Information
Lot# 660833A, Exp 08/31/18
