Bristol-Myers Squibb Recalls Mislabelled Kombiglyze XR Physician Sample Cartons
Bristol-Myers Squibb is recalling specific lots of Kombiglyze XR physician sample cartons because the external packaging was incorrectly labeled as 2.5mg/1000mg, while the contents were 5mg/500mg.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
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 due to a labeling error (miscart/mispack) where the external carton strength did not match the contents, but the individual blister units were correctly labeled, representing a minor labeling error with low risk of immediate harm.
Plain-English summary
Bristol-Myers Squibb Company is recalling certain lots of Kombiglyze XR (saxagliptin and metformin HCl extended-release) tablets, 5 mg/500 mg, in physician sample cartons. The recall is due to a labeling error where some external package cartons were incorrectly marked as Kombiglyze XR 2.5mg/1000mg, even though the blister-packaged tablets inside were the 5 mg/500 mg strength. The individual blister units within the cartons are labeled correctly.
The affected product is identified by the following lot numbers and expiration dates: Lot # 1J6024PA (Exp. 09/13), Lot # 1J6025PA (Exp. 09/13), Lot # 1K6049PA (Exp. 10/13), and Lot # 1L9015WA (Exp. 11/13). The product was distributed nationwide. The FDA has classified this recall as Class II, which indicates that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Physicians and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If found, the product should be removed from use and returned to the manufacturer or disposed of according to local regulations. Patients who have already taken the medication should consult their healthcare provider if they have concerns about the labeling discrepancy.
The recalled product
- Product
- Kombiglyze XR (saxagliptin and metformin HCl extended-release) tablets, Physician Sample-Not For Sale, 7 Tablets per Carton, 5 mg/500 mg, Rx only, Manufactured By: Bristol-Myers Squibb Company, Princeton NJ 08543, USA, Marketed By: Bristol-Myers Squibb Company, Princeton NJ…
- Manufacturer
- Bristol-myers Squibb Company
- Category
- Drug — Prescription Medication
- Hazard
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 (4)
- Lot # 1J6024PA
- 1J6025PA Exp. 09/13
- 1K6049PA Exp. 10/13
- 1L9015WA Exp. 11/13
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Bristol-myers Squibb Company 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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