Famotidine Tablet, Film Coated
FDA Recall NDC 0172-5728
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 0172-5728). A significant event, classified as Class II, was initiated on Jul 24, 2017 by Teva Pharmaceuticals Usa, Inc.. The reported reason for this action was: "Failed Tablet/Capsule Specification; out of specification for tablet weight"
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
July 2017 Class II Recall: Failed Tablet/Capsule Specification; out of specification for tablet weight
Recall Number
Class II Terminated
Failed Tablet/Capsule Specification; out of specification for tablet weight
Jul 24, 2017
Aug 09, 2017
28,188 bottles
Recall Profile & Regulatory Data
Event ID
77835
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Teva Pharmaceuticals USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Jan 31, 2018
Product Description
Famotidine Tablets USP, 20 mg, 100 count bottles, Rx only, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA --- NDC 0172-5728-60
Batch or Lot Expiration Information
Lot# 3429066, exp 06/2018
Affected Packages Involved in this Recall
0172-5728-60Product
0172-5728-70Product
0172-5728-80Product
0172-5729-60Product
0172-5729-70Product
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.
