Famotidine For Suspension
FDA Recall NDC 43386-500
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 Famotidine (NDC 43386-500). A significant event, classified as Class III, was initiated on Jun 20, 2014 by Lupin Pharmaceuticals,inc.. The reported reason for this action was: "Failed Impurity/Degradation Specification; 12-month stability time point"
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
June 2014 Class III Recall: Failed Impurity/Degradation Specification; 12-month stability time point
Recall Number
Class III Terminated
Failed Impurity/Degradation Specification; 12-month stability time point
Jun 20, 2014
Sep 03, 2014
25,776 containers
Recall Profile & Regulatory Data
Event ID
68722
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Novel Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Jun 29, 2015
Product Description
Famotidine for Oral Suspension, USP 40 mg/5 mL, Rx Only, Cherry-Banana-Mint Flavored, Not for Injection, Manufactured by: Novel Laboratories, Inc., Somerset, NJ 08873. Distributed by: Gavis Pharmaceuticals, LLC, Somerset, NJ 08873, NDC 43386-500-11.
Batch or Lot Expiration Information
Lot# 's M13075A, M13076A, M13076B, M13077A, M13077B all with expiry dated 2/2015 and M13490A with expiry date 3/2016.
Affected Packages Involved in this Recall
43386-500-11Product
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.
