Sun's US arm told to recall diabetes drug
P B Jayakumar Mumbai According to a USFDA Class II withdrawal announced on March 19, Caraco will have to withdraw seven lots of Metformin Hydrochloride in bottles of 100, 500 and 1000 tablets each.
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The withdrawal was necessitated by undersized and oversized tablets, which could result in patients not receiving the expected dose, said the regulator. Caraco has initiated the recall. The FDA said the recall was valid nationwide and 22,156 bottles of the drug were in circulation in the US. |
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In November 2007, the FDA had asked Ranbaxy Laboratories to withdraw its Gabapentine tablets 600 mg from the US market for excessive impurity specification. |
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The FDA had also suspended production at the manufacturing facilities of Leineur Health Systems, Dr Reddy
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