Invokamet Recalled for Incorrect or Missing Package Insert Labeling
Janssen Ortho L.L.C. is recalling Invokamet tablets because Xarelto prescribing information outserts may be affixed to the bottles instead of the correct Invokamet inserts.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences, fitting the 'Low' severity criteria for documentation or packaging-only problems.
Plain-English summary
Janssen Ortho L.L.C. is recalling 5,346 bottles of Invokamet (canagliflozin and metformin hydrochloride) tablets, 150 mg/1,000 mg, 60-count. The recall involves Lot # 16GG581X with an expiration date of 09/17. The product was distributed nationwide and in Puerto Rico.
The recall was initiated due to a labeling error where Xarelto prescribing information outserts may have been affixed to the exterior of Invokamet bottles in place of the correct Invokamet prescribing information outserts. This results in incorrect or missing package insert information for the Invokamet product.
Consumers with this specific lot of Invokamet should stop using the product and contact their healthcare provider or pharmacist for guidance. The FDA has classified this as a Class III recall, indicating that the violation is not likely to cause adverse health consequences.
The recalled product
- Product
- INVOKAMET (CANAGLIFLOZIN AND METFORMIN HYDROCHLORIDE)
- Brand
- INVOKAMET
- Manufacturer
- Janssen Ortho L.L.C.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 5,346
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 16GG581X
- Exp 09/17
UPCs (2)
- 0350458543605
- 0350458541601
Distribution
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