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Regulatory Focus™ > News Articles > 2020 > 6 > FDA names five companies recalling NDMA-contaminated metformin

FDA names five companies recalling NDMA-contaminated metformin

Posted 12 June 2020 | By Kari Oakes 

FDA names five companies recalling NDMA-contaminated metformin

The US Food and Drug Administration (FDA) announced on Thursday that five companies have now voluntarily recalled extended-release metformin drugs because of elevated levels of N-nitrosodimethylamine (NDMA), a potential carcinogen.

The five companies who were notified of the agency’s testing results and who are recalling their extended-release (ER) product, and specific labeling and lots recalled, are:
  • Apotex – all lots
  • Amneal – all lots
  • Marksans, branded as Time-Cap – one lot (XP9004)
  • Lupin – one lot (G901203)
  • Teva, branded as Actavis – 14 lots

There are additional companies that manufacture ER metformin and supply a significant portion of the US market, whose products are not being recalled at this time,” said FDA. Immediate release metformin formulations have not contained NDMA in the FDA’s testing thus far. The substance is ingested in low levels through normal dietary pathways but can raise the risk of cancer with long-term elevated exposure.

(RELATED: FDA recalls some ER metformin for NDMA impurity, Regulatory Focus 29 May 2020)

The agency has now posted updated results of its NDMA testing in a sortable tabular format that includes all companies whose product has been tested, which formulations and lots were tested, and what levels, if any, of NDMA were found.

A second testing method using liquid chromatography-electrospray ionization-high resolution mass spectrometry has been posted by the FDA “to provide an option for regulators and industry to detect eight different nitrosamine impurities in metformin drug substances and drug products,” said the agency.

Companies manufacturing ER metformin should evaluate the risk that it contains NDMA at elevated levels. Companies should conduct per-batch testing, notify the FDA of any test results showing NDMA above the acceptable intake limit, and not release that batch to the US market.
 

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