D-019-2013 Class II Terminated
FDA drug recall D-019-2013 was initiated by Bristol-Myers Squibb Company on Jun 5, 2012 and is designated Class II. 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… The recall status is terminated (terminated Jul 10, 2013).
Recall Details
- Product Type
- Drugs
- Report Date
- Oct 31, 2012
- Initiation Date
- Jun 5, 2012
- Termination Date
- Jul 10, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
Product Description
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.
Distribution Pattern
Nationwide
Code Information
Lot # 1J6024PA, 1J6025PA Exp. 09/13; 1K6049PA Exp. 10/13; 1L9015WA Exp. 11/13
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-019-2013
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026