Pantoprazole Sodium Tablet, Delayed Release
FDA Recall NDC 13668-429
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 Pantoprazole Sodium (NDC 13668-429). A significant event, classified as Class II, was initiated on Apr 11, 2022 by Torrent Pharmaceuticals Limited. The reported reason for this action was: "CGMP deviations: tablets cracking"
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
CGMP deviations: tablets cracking
Apr 11, 2022
May 11, 2022
24,888 bottles
Recall Profile & Regulatory Data
Event ID
89992
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Torrent Pharma Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the U.S.A
Termination Date
Jul 25, 2023
Product Description
Pantoprazole Sodium Delayed-Release Tablets, USP, 20 mg, Rx Only, 90 tablets per bottle, Manufactured by: Torrent Pharmaceuticals Ltd., Indrad-382 721, India, Manufactured for: Torrent Pharma Inc., Levittown, PA 19057, NDC# 13668-096-90.
Batch or Lot Expiration Information
Lot# s: BA34G021, BA34G022, Exp. 09/2022
Affected Packages Involved in this Recall
13668-096-90Product
13668-429-30Product
13668-429-05Product
13668-429-90Product
13668-429-10Product
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.
