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 Co

FDA recall notice · announced October 31, 2012 · Bristol-myers Squibb

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Reason for recall

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.

Notes

Distribution: Nationwide
Lot/code information: Lot # 1J6024PA, 1J6025PA Exp. 09/13; 1K6049PA Exp. 10/13; 1L9015WA Exp. 11/13
Quantity: N/A
Status: Terminated
Products in this recall event:
- 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, Pri (D-018-2013)
- 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, Prince (D-019-2013)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.