The Recall Desk

FDA (Drugs) recall action 62898

Bristol-myers Squibb Company recalled 2 products on 2012-10-31

The FDA (Drugs) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2012-10-31
Critical
0
Units
117,049

Why these products were 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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • ModerateFDA (Drugs)··2012-10-31

    Bristol-Myers Squibb Recalls Mislabelled Kombiglyze XR Physician Sample Cartons

    Bristol-Myers Squibb is recalling specific lots of Kombiglyze XR physician sample cartons because the external packaging was incorrectly labeled as 2.5mg/1000mg, while the contents were 5mg/500mg.

    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
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2012-10-31

    Bristol-Myers Squibb Recalls Mispackaged Kombiglyze XR Physician Sample Cartons

    Bristol-Myers Squibb is recalling 117,049 physician sample cartons of Kombiglyze XR because some external cartons were mislabeled with the wrong dosage, though the individual blister units inside are correctly labeled.

    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 08
    Category
    Distribution
    0 states