Why it was recalled
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 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
Lot numbers, UPCs & expiration codes
Lot #: 16GG581X, Exp 09/17
Where it was sold
Nationwide and Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0115-2017
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Oct 19, 2016
- FDA report date
- Nov 2, 2016
- Quantity
- 5346 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Janssen Ortho L.L.C.
Original FDA data
Every field from FDA enforcement report D-0115-2017, exactly as published.
Show all FDA fields
- City
- Gurabo
- State
- PR
- Status
- Terminated
- Country
- United States
- Event ID
- 75449
- Address
- Carr # 933 Km 0.1
- Code information
- Lot #: 16GG581X, Exp 09/17
- Postal code
- 00778
- Report date
- Nov 2, 2016
- Product type
- Drugs
- Recall number
- D-0115-2017
- Classification
- Class III
- Recalling firm
- Janssen Ortho L.L.C.
- Product quantity
- 5346 bottles
- Termination date
- May 14, 2018
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Oct 19, 2016
- Center classification date
- Oct 25, 2016