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.
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.
Lot numbers, UPCs & expiration codes
Lot # 1J6024PA, 1J6025PA Exp. 09/13; 1K6049PA Exp. 10/13; 1L9015WA Exp. 11/13
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-019-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 5, 2012
- FDA report date
- Oct 31, 2012
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Bristol-myers Squibb Company
Original FDA data
Every field from FDA enforcement report D-019-2013, exactly as published.
Show all FDA fields
- City
- New Brunswick
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 62898
- Address
- 1 Squibb Dr
- Code information
- Lot # 1J6024PA, 1J6025PA Exp. 09/13; 1K6049PA Exp. 10/13; 1L9015WA Exp. 11/13
- Postal code
- 08901
- Report date
- Oct 31, 2012
- Product type
- Drugs
- Recall number
- D-019-2013
- Classification
- Class II
- Recalling firm
- Bristol-myers Squibb Company
- Termination date
- Jul 10, 2013
- 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.
- 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.
- Distribution pattern
- Nationwide
- Recall initiation date
- Jun 5, 2012
- Initial firm notification
- Letter
- Center classification date
- Oct 24, 2012