Janssen Ortho L.L.C. recalls Invokamet (canagliflozin and metformin HCl) tablets, 150 mg/1,000 mg, 60-count bottle, Rx only, Finished product manufa
Recalled November 2, 2016 · FDA recall D-0115-2017 · Janssen Ortho L.L.C
Hazard
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. · FDA Class III
Units
5346 bottles
Sold at
Nationwide and Puerto Rico
Description
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.
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
Manufacturer(s)
Janssen Ortho L.L.C.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →