Nitrofurantoin Monohydrate/ Macrocrystalline Capsule
FDA Recall NDC 47781-303
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Nitrofurantoin Monohydrate/ Macrocrystalline (NDC 47781-303). A significant event, classified as Class II, was initiated on Jul 24, 2019 by Alvogen Inc.. The reported reason for this action was: "Failed dissolution specifications"
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 dissolution specifications
Jul 24, 2019
Aug 21, 2019
2784 bottles
Recall Profile & Regulatory Data
Event ID
83434
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Alvogen, Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Natonwide, PR
Termination Date
Aug 04, 2021
Product Description
Nitrofurantoin Monohydrate/Macrycrystals Capsules, 100 mg, 100-count bottle, Rx Only, Distributed by: Alvogen, Inc. Pine Brook, NY 07058 USA, NDC 47781-303-01
Batch or Lot Expiration Information
Lot# 471976, Exp 03/2020
Affected Packages Involved in this Recall
47781-303-01Product
April 2015 Class II Recall: Failed Dissolution Specification; 6 month time point
Recall Number
Class II Terminated
Failed Dissolution Specification; 6 month time point
Apr 21, 2015
May 20, 2015
13,392 bottles (100 count)
Recall Profile & Regulatory Data
Event ID
71003
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Alvogen, Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico
Termination Date
Dec 04, 2015
Product Description
NITROFURANTOIN MONOHYDRATE/MACROCRYSTALS CAPSULES, 100 mg, 100 count bottle, Rx Only --- Distributed by Alvogen, Inc. Pine Brook, NJ 07058; NDC 47781-303-01
Batch or Lot Expiration Information
Lot# Lot 457529, exp. 08/2016
Affected Packages Involved in this Recall
47781-303-01Product
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.
