FDA recall D-0115-2017

Product

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

Nationwide and Puerto Rico

Key facts

Status

Terminated

Initiation date

2016-10-19

Report date

2016-11-02

Termination date

2018-05-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Gurabo, PR, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0115-2017