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

FDA recall notice · announced November 2, 2016 · Janssen Ortho

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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.

Notes

Distribution: Nationwide and Puerto Rico
Lot/code information: Lot #: 16GG581X, Exp 09/17
Quantity: 5346 bottles
Status: Terminated
Products in this recall event:
- 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 Pharmac (D-0115-2017)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.