Drugs

Recall NDMA-Contaminated Metformin: Valisure

David McFarland

— 2 min read
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Valisure, which describes itself as an online pharmacy and analytic laboratory that is accredited by the International Organization for Standardization and registered with FDA and the Drug Enforcement Administration, says it has tested and detected high levels of N-Nitrosodimethylamine (NDMA) in specific batches of prescription drug products containing metformin, used to control hypertension in patients with Type 2 diabetes. In a 3/2 citizen petition, Valisure calls on FDA to: 

  •          request a recall of identified batches of metformin;
  •          examine the products their manufacturing processes, and the manufacturer submissions made for FDA approval and effect labeling revisions as needed;
  •          provide information to the public on the products;
  •          update and revise FDA guidance documents to include the Valisure analytical methodology for improved quantitation of NDMA in metformin and to avoid underestimating NDMA levels; and
  •          promulgate regulations requiring robust independent chemical batch-level testing and verification of the chemical content of batches of pharmaceuticals of drugs and, which the regulations are pending, issue guidance requesting such testing and verification.

In its petition, Valisure notes that FDA already recognizes the danger of NDMA and has set a strict daily acceptable intake limit of NDMA in pharmaceuticals of 96 nanograms. It references recalls of angiotensin receptor blocker drugs and ranitidine-containing drugs. “It is important to note that the presence of NDMA in metformin products may be primarily due to contamination during manufacturing as opposed to a fundamental instability of a drug molecule, which is the case with ranitidine,” the petition says.

The company says it is aware that FDA has expressed concern over NDMA contamination in metformin and said on 2/3 that no sample of metformin tested by FDA exceeded the acceptable daily intake level. Valisure says it tested drugs from 22 companies selling metformin and a total of 38 batches, with 16 batches from 11 companies with NDMA levels above the acceptable daily limit. It says that several batches contained over 10 times the acceptable daily level and there was significant variability from batch to batch, even within a single company.

“Valisure’s results will be of significant concern to medical practitioners who already struggle to prescribe safe medications and who rely on external government and private sector oversight to ensure contaminant-free drugs,” the petition says. “Due to the discovery of significant levels of NDMA contamination, Valisure’s pharmacy will not sell the affected batches of metformin it has acquired and Valisure cannot obtain a refund for these tainted products because they have not been recalled.”

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