Nitrofurantoin Suspension
FDA Recall NDC 43386-450
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 (NDC 43386-450). A significant event, classified as Class II, was initiated on Dec 21, 2018 by Lupin Pharmaceuticals,inc.. The reported reason for this action was: "Subpotent Drug: Expansion of June 2018 recall of lots S700065 and S700619 due to below specification results for assay."
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
Subpotent Drug: Expansion of June 2018 recall of lots S700065 and S700619 due to below specification results for assay.
Dec 21, 2018
Jan 09, 2019
23,460 bottles
Recall Profile & Regulatory Data
Event ID
81865
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
LUPIN SOMERSET
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA and Puerto Rico.
Termination Date
Mar 15, 2023
Product Description
Nitrofurantoin Oral Suspension, USP, 25mg/5mL, 230 mL bottle, Rx only, Manufactured by: Novel Laboratories, Inc., Somerset, NJ 08873; Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, NDC 43386-450-11.
Batch or Lot Expiration Information
Lot# : S700038, S700044, S700059, S700065, Exp 28-Feb-19; S700410, S700427, Exp 30-Jun-19; S700617, S700619, Exp 31-Aug-19; S700813, S700815, S700869, Exp 31-Oct-19; S700871, S700873, Exp 30-Nov-19; S700875, S701073, Exp 31-Dec-19.
Affected Packages Involved in this Recall
43386-450-11Product
Class II Terminated
Subpotent Drug and Failed Content Uniformity.
Jun 28, 2018
Jul 18, 2018
3456 cartons
Recall Profile & Regulatory Data
Event ID
80377
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
LUPIN SOMERSET
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the US
Termination Date
Mar 06, 2023
Product Description
Nitrofurantoin Oral Suspension USP, 25mg/5mL, 230 mL Bottle, Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202, UPC 343386-450-114, NDC 43386-450-11
Batch or Lot Expiration Information
Lot# : S700065, Exp. 02/2019; 700619, Exp. 08/2019
Affected Packages Involved in this Recall
43386-450-11Product
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.
