Nitrofurantoin (monohydrate/macrocrystals) Capsule
FDA Recall NDC 0185-0122
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Nitrofurantoin (monohydrate/macrocrystals) (NDC 0185-0122). A significant event, classified as Class III, was initiated on Nov 02, 2018 by Sandoz Inc. The reported reason for this action was: "Cross Contamination with Other Products"
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 III Terminated
Cross Contamination with Other Products
Nov 02, 2018
Nov 21, 2018
14366 bottles
Recall Profile & Regulatory Data
Event ID
81457
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Sandoz Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Termination Date
Oct 02, 2020
Product Description
Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg, packaged in a) 100-capsule bottles (NDC 0185-0122-01); and b) 1000-capsule bottles, (NDC 0185-0122-10); Rx Only, Distributed by Sandoz Inc. Princeton, NJ 08540
Batch or Lot Expiration Information
Lot# Lots: a) JB4952, JA7322 Exp. 03/2020; b) JA7324, Exp.03/2020
Affected Packages Involved in this Recall
0185-0122-01Product
0185-0122-10Product
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.
