Furosemide Tablet
FDA Recall NDC 0054-8299
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 3 recorded enforcement report(s) associated with Furosemide (NDC 0054-8299). A significant event, classified as Class II, was initiated on Dec 22, 2016 by Hikma Pharmaceuticals Usa Inc.. The reported reason for this action was: "Failed Tablet/Capsule Specifications: An unusually thick tablet was reported through a complaint."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Failed Tablet/Capsule Specifications: An unusually thick tablet was reported through a complaint.
Dec 22, 2016
Feb 01, 2017
6493 bottles
Recall Profile & Regulatory Data
Event ID
76142
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Roxane Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Dec 18, 2017
Product Description
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
Affected Packages Involved in this Recall
0054-4297-31Product
0054-4297-25Product
0054-8297-25Product
0054-4299-31Product
0054-4299-25Product
0054-8299-25Product
0054-4301-29Product
0054-4301-25Product
0054-8301-25Product
0054-3298-63Product
0054-3294-50Product
0054-3294-46Product
Class III Terminated
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.
Sep 25, 2015
Oct 21, 2015
11,110 bottles
Recall Profile & Regulatory Data
Event ID
72234
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Boehringer Ingelheim Roxane Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico
Termination Date
Feb 19, 2016
Product Description
FUROSEMIDE Tablets USP, 20 mg, 1000-count bottle, Rx only, Boehringer Ingelheim Roxane Laboratories, Roxane Laboratories, Inc., Columbus, OH 43216, NDC 0054-4297-31, UPC 3 0054-4297-31 8.
Batch or Lot Expiration Information
Lot# : 559660P, 559661P, Exp 03/17
Affected Packages Involved in this Recall
0054-4297-31Product
0054-4297-25Product
0054-8297-25Product
0054-4299-31Product
0054-4299-25Product
0054-8299-25Product
0054-4301-29Product
0054-4301-25Product
0054-8301-25Product
0054-3298-63Product
0054-3294-50Product
0054-3294-46Product
Class III Terminated
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.
Sep 25, 2015
Oct 21, 2015
5,160 bottles
Recall Profile & Regulatory Data
Event ID
72234
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Boehringer Ingelheim Roxane Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico
Termination Date
Feb 19, 2016
Product Description
FUROSEMIDE Tablets USP, 40 mg, 1000-count bottle, Rx only, Boehringer Ingelheim Roxane Laboratories, Roxane Laboratories, Inc., Columbus, OH 43216, NDC 0054-4299-31, UPC 3 0054-4299-31 2.
Batch or Lot Expiration Information
Lot# : 559310P, Exp 02/17; 559664B, Exp 04/17
Affected Packages Involved in this Recall
0054-4297-31Product
0054-4297-25Product
0054-8297-25Product
0054-4299-31Product
0054-4299-25Product
0054-8299-25Product
0054-4301-29Product
0054-4301-25Product
0054-8301-25Product
0054-3298-63Product
0054-3294-50Product
0054-3294-46Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
