# FDA recall D-019-2013

> **Bristol-myers Squibb Company** · Class II · drug recall initiated 2012-06-05.

## 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.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-019-2013
- **Recalling firm:** Bristol-myers Squibb Company
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2012-06-05
- **Report date:** 2012-10-31
- **Termination date:** 2013-07-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** New Brunswick, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-019-2013

## Citation

> AI Analytics. FDA recall D-019-2013. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-019-2013. Source: US FDA. Licensed CC0.

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