Bristol-Myers Squibb Recalls Mispackaged Kombiglyze XR Physician Sample Cartons
Bristol-Myers Squibb is recalling 117,049 physician sample cartons of Kombiglyze XR because some external cartons were mislabeled with the wrong dosage, though the individual blister units inside are correctly labeled.
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, which typically corresponds to a moderate severity score. The hazard involves a labeling and mispackaging error where the external carton does not match the contents, but the individual units are correctly labeled, reducing the immediate risk of harm compared to a Class I recall.
Plain-English summary
Bristol-Myers Squibb Company is recalling 117,049 cartons of Kombiglyze XR (saxagliptin and metformin HCl extended-release) tablets, specifically the Physician Sample-Not For Sale version. The recall involves three specific lots: 1J6024PA and 1J6025PA (expiring 09/13), 1K6049PA (expiring 10/13), and 1L9015WA (expiring 11/13). The product was distributed nationwide.
The recall was initiated due to a labeling and mispackaging error. Some external package cartons were incorrectly labeled as containing Kombiglyze XR 2.5 mg/1000 mg tablets, while the actual contents were Kombiglyze XR 5 mg/500 mg blister-packaged tablets. The source text confirms that the individual blister units inside the cartons are labeled correctly.
This recall affects physicians who may have received these specific sample cartons. Because the individual blister units are correctly labeled, the risk is limited to potential confusion regarding the external carton contents. Consumers and healthcare providers should verify the labeling on the individual blister units before use and contact the manufacturer or their local FDA office with questions regarding this recall.
The recalled product
- Product
- Kombiglyze XR (saxagliptin and metformin HCl extended-release) tablets, Physician Sample-Not For Sale, 6 Tablets per Carton, 2.5 mg/1000 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
- Affected units
- 117,049
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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