Cardinal Health Recalls Jentadueto XR Due to Temperature Excursions
Cardinal Health Inc. is recalling 52 bottles of Jentadueto XR tablets due to intermittent exposure to temperature excursions during storage.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a CGMP deviation (temperature excursion) without reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Cardinal Health Inc. is recalling 52 bottles of Jentadueto XR (linagliptin and metformin hydrochloride extended-release) tablets, 5 mg/1000 mg, 30-count bottles. The product is distributed by Boehringer Ingelheim Pharmaceuticals, Inc. The recall is limited to NDC 0597-0275-33 with code 3189866.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations involving intermittent exposure to temperature excursions during storage. This condition may affect the stability or quality of the medication.
The affected product was distributed in Florida, Georgia, and South Carolina. Patients and healthcare providers should stop using the recalled product and contact their healthcare provider or pharmacist for a replacement or alternative treatment.
The recalled product
- Product
- JENTADUETO XR (LINAGLIPTIN AND METFORMIN HYDROCHLORIDE)
- Brand
- JENTADUETO XR
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 52
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 (1)
- 3189866
Distribution
Part of a larger recall action
This product is one of 198 recalled by Cardinal Health Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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