AurobindoPharma USA announced its voluntary recall on Friday of 38 lots of medication that included tablets of valsartan and another in which valsartan is combined with amlodipine. The recalled products vary in dosage from 40 mg to 320 mg, and have expiration dates that range from October 2019 to July 2020.
AurobindoPharma, which is based out Hyderabad, India, distributed its tainted products to US pharmacies under the names of AurobindoPharma USA and Acetris Health LLC. Its announcement is an expansion to a recall that the company first initiated in December 2018 on 80 lots.
"To date, AurobindoPharma USA, Inc. has not received any reports of adverse events related to this recall," a statement from the US Food and Drug Administration (FDA) reads. It further explained that the NDEA found in AurobindoPharma's products "is a substance that occurs naturally in certain foods, drinking water, air pollution and industrial processes."
AurobindoPharma's declaration comes just one day after Camber Pharmaceuticals announced its very own recall of 87 lots of Losartan tablets with the designated strengths of 25 mg, 50mg and 100 mg.
"This recall was prompted due to the detection of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA), a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, Unit — I (API manufacturer)," explained the company's Thursday release.
It added that it, too, "has not received any reports of adverse events related to this recall."
Camber's products, which are packaged into 30-count, 90-count, 500-count and 1,000-count bottles, were distributed nationwide via US "wholesalers, distributors, retail pharmacies and mail-order pharmacies."
Presently, Illinois-based compliance company Stericycle is working with Camber to notify distributors and customers of the recall. The affected Losartan tablets have expiration dates that range from September 2019 to June 2020.
And then there's Macleods Pharmaceuticals Limited, which announced on February 22, 2019, that it was initiating a recall on just one of its lots of Losartan tablets after traces of NDEA were detected by officials. The specified lot has a July 2019 expiration date and comes in 90-count bottles.
In a statement, FDA Commissioner Scott Gottlieb explained that the agency has been carrying out a series of investigations for several months after various companies began announcing their voluntary recalls.
"FDA scientists have developed novel and sophisticated testing methods specifically designed to detect and measure N-Nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA) impurities in [angiotensin II receptor blocker (ARB)] medicines," Gottlieb wrote. ARB drugs are used to treat high blood pressure and heart failure.
"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."
"The FDA is committed to implementing measures to prevent the formation of these impurities during drug manufacturing processes in the future," he added.
Other companies that announced recalls in December 2018 include Mylan Pharmaceuticals and Torrent Pharmaceuticals, whose products contained NDEA. Incidentally, Hetero Labs Limited was also listed as the source of the contamination in both recalls.