Camber's products, which are packaged into 30-count, 90-count, 500-count and 1,000-count bottles, were distributed nationwide via U.S. "wholesalers, distributors, retail pharmacies and mail-order pharmacies". Hetero Labs Limited produced the active ingredient.
The drugs, including losartan, belong to a class of widely used medicines for treating high blood pressure called angiotensin II receptor blockers, or ARBs.
"That said, any presence of such impurities in drug products is not acceptable".
Camber said in a statement on Thursday that it was recalling 87 lots of losartan tablets due to the discovery. NMBA had not been found in previously recalled ARB products, but the FDA continues its investigations.
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The previous recalls of Losarta, Valsartan or Irbesartan involved too much N-Nitrosodiethylamine (NDEA) or N-nitrosodimethylamine (NDMA). A full record of recalled drugs is offered from the FDA.
"Because of the potential for discovering other nitrosamine impurities, we are conducting an extensive organic chemistry analysis to develop novel testing methods to detect additional nitrosamine impurities, including NMBA".
"We're continuing to share these testing methods with worldwide regulators, industry and the public to help manufacturers and other regulators evaluate these products for any potential nitrosamine impurity". Other companies to announce recalls include Maylan, Aurobindo Pharma and Torrent Pharmaceuticals, which also listed Hetero Labs as the source of the contamination in its recall. Zhejiang Huahai has said it has been in close contact with the FDA since the recall began.
"The FDA is committed to implementing measures to prevent the formation of these impurities during drug manufacturing processes in the future", he added. It's the first ARB recall involving the presence of NMBA, which is the third type of nitrosamine impurity detected in the medications, the FDA said.