Lansoprazole Capsule, Delayed Release Pellets
FDA Recall NDC 0378-8030

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 0378-8030). A significant event, classified as Class II, was initiated on Jan 30, 2013 by Mylan Pharmaceuticals Inc.. The reported reason for this action was: "Presence of Foreign Tablets/Capsules: Bottles of lansoprazole 30 mg delayed-release capsules may contain topiramate 100 mg tablets."

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

D-147-2013TERMINATED

January 2013 Class II Recall: Presence of Foreign Tablets/Capsules

Recall Number
D-147-2013
Class II Terminated
Reason for Recall
Presence of Foreign Tablets/Capsules: Bottles of lansoprazole 30 mg delayed-release capsules may contain topiramate 100 mg tablets.
Initiated
Jan 30, 2013
Reported
Feb 13, 2013
Quantity
1,894 bottles

Recall Profile & Regulatory Data

Event ID
64186
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Mylan Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Dec 23, 2013
Product Description
Lansoprazole Delayed-release Capsules, USP, 30 mg, 500-count capsules per bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., Made in India, NDC 0378-8030-05.
Batch or Lot Expiration Information
Lot# : 1110829, Exp 05/14
Affected Packages Involved in this Recall
0378-8015-93Product
0378-8030-93Product
0378-8030-77Product
0378-8030-05Product

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.