Lansoprazole Tablet, Orally Disintegrating, Delayed Release
FDA Recall NDC 0093-3009
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 Lansoprazole (NDC 0093-3009). A significant event, classified as Class III, was initiated on Mar 11, 2019 by Teva Pharmaceuticals Usa, Inc.. The reported reason for this action was: "Subpotent Drug."
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
Subpotent Drug.
Mar 11, 2019
Mar 27, 2019
7,081 bottles
Recall Profile & Regulatory Data
Event ID
82367
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Teva Pharmaceuticals USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the United States.
Termination Date
Nov 15, 2019
Product Description
Lansoprazole Delayed-Release Orally Disintegrating Tablets, 15 mg, 100 tablets (10 blister cards of 10 tablets each), Rx only, Manufactured in Israel By: Teva Pharmaceutical Ind. Ltd. Jerusalem, 9777402, Israel, Manufactured for: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, NDC 0093-3008-93
Batch or Lot Expiration Information
Lot# : 25Q002, Exp. 11/2019
Affected Packages Involved in this Recall
0093-3008-19Product
0093-3008-93Product
0093-3009-19Product
0093-3009-93Product
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.
