D-0115-2017 Class III Terminated
FDA drug recall D-0115-2017 was initiated by Janssen Ortho L.L.C. on October 19, 2016 and is designated Class III. 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. The recall status is terminated (terminated May 14, 2018). Affected quantity: 5346 bottles.
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