Class III
Terminated
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
- Company
- Janssen Ortho L.L.C.
- Recall Initiated
- October 19, 2016
- Posted
- November 2, 2016
- Recall Number
- D-0115-2017
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 5346 bottles
- Firm Location
- Gurabo, PR, United States
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
Lot / Code Info
Lot #: 16GG581X, Exp 09/17
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