Recalls / Class II
Class IID-018-2013
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.
- Affected lot / code info
- Lot # 1J6024PA , 1J6025PA Exp. 09/13; 1K6049PA Exp. 10/13; 1L9015WA Exp. 11/13
Why it was recalled
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.
Recalling firm
- Firm
- Bristol-myers Squibb Company
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Squibb Dr, N/A, New Brunswick, New Jersey 08901
Distribution
- Quantity
- 117,049 Sample Cartons
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2012-06-05
- FDA classified
- 2012-10-24
- Posted by FDA
- 2012-10-31
- Terminated
- 2013-07-10
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-018-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.