Bristol-myers Squibb Company: Labeling; Correct labeled product miscart/mispack: Some Physician sample cartons were incorrectly labeled as Kombiglyze XR 2.5mg/1000mg on the external package carton, whereas the contents were Kombiglyze XR 5 mg/500 mg blister packaged tablets. The individual blister units are labeled correctly.

Agency Publication Date: June 30, 2015

Affected Products

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 08543, USA and AstraZeneca Pharmaceuticals LP, Wilmington DE 19850.

Lot # 1J6024PA , 1J6025PA Exp. 09/13; 1K6049PA Exp. 10/13; 1L9015WA Exp. 11/13

Lot Numbers:

1J6024PA

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 08543, USA and AstraZeneca Pharmaceuticals LP, Wilmington DE 19850.

Lot # 1J6024PA, 1J6025PA Exp. 09/13; 1K6049PA Exp. 10/13; 1L9015WA Exp. 11/13

Lot Numbers:

1J6024PA

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 62898

Status: Resolved

Manufacturer: Bristol-myers Squibb Company

Manufactured In: United States

Units Affected: 117,049 Sample Cartons

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Sources: FDA iRES · Raw API Response

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Affected Products

Lot # 1J6024PA , 1J6025PA Exp. 09/13; 1K6049PA Exp. 10/13; 1L9015WA Exp. 11/13

Lot Numbers:

1J6024PA

Lot # 1J6024PA, 1J6025PA Exp. 09/13; 1K6049PA Exp. 10/13; 1L9015WA Exp. 11/13

Lot Numbers:

1J6024PA