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Teva recalls 39,000 bottles of drug products due to manufacturing standards violations

May 27, 2014
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The U.S. Food and Drug Administration (FDA) has announced the recall of nearly 39,000 bottles of an anti-diabetes drug, a hypertension drug and an anti-inflammatory product manufactured by Indian supplier Emcure Pharmaceuticals for Israeli giant Teva. The reason given for the recall is violation of manufacturing standards, according to media reports that quoted the FDA.

The recalled production includes 2,532 bottles of anti-diabetes drug glyburide, which are being pulled off the U.S. market due to deviations from Current Good Manufacturing Practice (CGMP), the Economic Times reported. Data from the regulator shows that the recall of the four lots of glyburide was started on March 24.

The second product, anti-inflammatory drug indomethacin, 25 mg and 50 mg, is also being withheld due to CGMP violations. Some 7,694 bottles of the former type of packaging and a further 5,812 bottles of the latter are included in the recall.

The last drug, methyldopa tablets, intended to treat high blood pressure, accounts for the biggest proportion of recalled products. According to the Economic Times, 22,820 bottles of methyldopa are being recalled because of sub-standard manufacturing practices.

Information provided by the U.S. drug regulator describes the recall as Class II, meaning that exposure to such drugs could cause reversible or temporary health consequences, with a "remote probability" for serious consequences. Neither Teva nor Emcure Pharmaceuticals were available for comment, the newspaper said.

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