Home / Recalls / Janssen Ortho L.L.C. / D-0115-2017

D-0115-2017 Class III Terminated

Recalled by Janssen Ortho L.L.C. — Gurabo, PR

Recall Details

Product Type: Drugs
Report Date: November 2, 2016
Initiation Date: October 19, 2016
Termination Date: May 14, 2018
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 5346 bottles

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

Reason for Recall

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.

Distribution Pattern

Nationwide and Puerto Rico

Code Information

Lot #: 16GG581X, Exp 09/17