Invokamet Xr Tablet, Film Coated, Extended Release
FDA Recall NDC 50458-943
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 Invokamet Xr (NDC 50458-943). A significant event, classified as Class III, was initiated on Oct 19, 2016 by Janssen Pharmaceuticals, Inc.. The reported reason for this action was: "Labeling: Incorrect or Missing Package Insert - Xarelto prescribing information outserts may be affixed to the exterior of Invokamet bottles in place of the Invokamet prescribing information outsert."
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
Labeling: Incorrect or Missing Package Insert - Xarelto prescribing information outserts may be affixed to the exterior of Invokamet bottles in place of the Invokamet prescribing information outsert.
Oct 19, 2016
Nov 02, 2016
5346 bottles
Recall Profile & Regulatory Data
Event ID
75449
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Janssen Ortho L.L.C.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico
Termination Date
May 14, 2018
Product Description
Invokamet (canagliflozin and metformin HCl) tablets, 150 mg/1,000 mg, 60-count bottle, Rx only, Finished product manufactured by: Janssen Ortho, LLC, Gurabo PR 00778, Manufactured for: Janssen Pharmaceuticals, Inc., Titusville, NJ 08560, NDC 50458-543-60
Batch or Lot Expiration Information
Lot# : 16GG581X, Exp 09/17
Affected Packages Involved in this Recall
50458-540-60Product
50458-540-91Product
50458-541-60Product
50458-541-91Product
50458-542-60Product
50458-542-91Product
50458-543-60Product
50458-543-91Product
50458-940-01Product
50458-940-02Product
50458-941-01Product
50458-941-02Product
50458-942-01Product
50458-942-02Product
50458-943-01Product
50458-943-02Product
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.
