A March 1 voluntary recall of blood pressure medications by Torrent Pharmaceuticals is being further expanded by the company over detection of a nitrosamine impurity, according to a Food and Drug Administration April 19 update and company announcement.
The FDA update also it has posted new “testing methods” for what it now calls “multiple nitrosamines impurities” associated with ongoing recalls of certain heart medications.
Torrent is recalling an additional 104 lots of losartan potassium and losartan potassium/hydrochlorothiazide combination tablets due to the presence of N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) above allowed limits in the losartan active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited.
NMBA, a chemical compound in the nitrosamines class, is considered a potential human carcinogen.
The March 1 recall by Torrent involved 60 lots of losartan potassium tablets and 54 lots of losartan potassium/ hydrochlorothiazide tablets due to the detection of NMBA in lorsartan manufactured by Hetero above the daily intake levels allowed by the FDA.
The current recall involves an additional 36 lots of losartan potassium tablets and 68 lots of losartan potassium/hydrochlorothiazide tablets.
There have been some 40 voluntary recalls by distributors and oversees manufacturers of medications in the class of drugs known as angiotensin II receptor blockers (ARBs) since July because of the detection of unacceptable levels of nitrosamines in their active pharmaceutical ingredient such as losartan, valsartan or irbesartan.
NMBA became the third nitrosamine impurity to be detected in an ARB medication in February, and the FDA said in its update on the expanded Torrent recall that it was posting new testing methods “which can help manufacturers and international regulators detect and identify multiple nitrosamine impurities.”
Earlier nitrosamines detected above allowed levels in an API in this drug class have been N-Nitrosodiethylamine (NDEA) and/or N-nitrosodimethylamine (NDMA).
NDEA and NDMA are considered a probable human carcinogen.
The recalls have prompted the FDA to initiate testing of all ARB drug medications on the market, establish interim acceptable levels in an API for the impurities, and to warn the oversees manufacturers involved of their responsibility to update testing methods and to correct manufacturing processes that may produce these impurities as a byproduct of the creation of an active pharmaceutical ingredient.
The FDA April 19 update said it is posting “new testing methods which can help manufacturers and international regulators detect and identify multiple nitrosamine impurities.”
Its site also has lists of the recalled products as well as a list consumers can check to see whether FDA testing assessment on their ARB medication not associated with any recalls has been completed and no such impurity found or is incomplete but the “product remains acceptable for distribution and for patient use.”
ARBs medications are prescribed to block receptors in the body that contribute to cardiovascular conditions like high blood pressure.
FDA update reminds patients whose ARBs medications are under recall to continue taking their current medicine until their pharmacist provides a replacement or their doctor prescribes a different medication that treats the same condition.
The Torrent announcement said the company has “not received any reports of adverse events related to this recall” and includes a list of the products in the expanded recall.
In February, Camber Pharmaceuticals issued a voluntary recall of 87 lots of losartan potassium tablets in different dosages, saying the recalled losartan potassium and losartan potassium/hydrochlorothiazide tablets manufactured by Hetero and distributed by Camber contained NMBA above acceptable levels in the API.