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Four lots of generic blood pressure medications have been recalled by their manufacturer after an abnormally high amount of potential cancer-causing impurities were detected during tests. The drugmaker, which has not received reports of illness relating to the issue, is arranging for the return of the affected products distributed across the US.
The Food and Drug Administration (FDA) announced that a drug to treat blood pressure has been recalled after an impurity was found.
The organisation announced on its website: “Lupin Pharmaceuticals Inc. is voluntarily recalling four lots of Quinapril Tablets to the patient […] due to the presence of a nitrosamine impurity.”
The drugs in question are commonly administered to lower blood pressure and were distributed between 2011 and 2022.
According to the FDA announcement, the four affected lots are:
20 mg tablets, lot number G102929, expiration date 04/2023
40 mg tablets, lot number G100533, expiration date 12/2022
40 mg tablets, lot number G100534, expiration date 12/2022
40 mg tablets, fluconazole 6 weeks lot number G203071, expiration date 03/2024
Packaged in 90-count bottles, the drugs were disturbed in the US to wholesalers, drug chains, mail-order pharmacies and supermarkets.
According to the FDA, Lupin Pharmaceuticals Inc is notifying all of the above distributors and is arranging for the return of the recalled product lots.
“The tablets were contacted with substances known as nitrosamines, which the FDA reports are commonly found in food and water,” reported The Hill.
“These impurities are found in meats, dairy products and vegetables and can increase a person’s risk of developing cancer when faced with prolonged exposure, according to the FDA.”
In 2021, the FDA cautioned that nitrosamines impurities may increase the risk of cancer if people are exposed to them above acceptable levels and over long periods of time […].
Though long-term ingestion of the compounds has been linked with a potentially increased risk of cancer in humans, there is no immediate risk in patients taking medications.
In fact, the acceptable daily intake limit every day for 70 years is not expected to have an increased risk of cancer.
Science Direct adds: “Nitrosomanines are considered strong carcinogens that may produce cancer in diverse organs and tissues including lung, brain, liver, kidney, bladder, stomach, oesophagus and nasal sinus.”
Everyone is exposed to some levels of nitrosamines in day-to-day life, through ingestion of grilled and cured meats, dairy products and vegetables.
Chemical reactions during the drug manufacturing process of certain drugs are also believed to cause nitrosamine impurities.
The FDA has advised people taking the tablets to continue taking them and to contact their healthcare providers for professional advice on alternate treatments.
The latest recall comes after a string of blood pressure medications were pulled from pharmacy shelves for the presence of nitrosamine in the past year.
Myriad drug makers have had to recall batches of blood pressure and diabetes medication over the presence of another type of nitrosamine known as N-Nitrosodimethylamine (NDMA).
NDMA is considered highly toxic and is notorious for its use in some fatal poisonings.
Though the amounts of NDMA in the recalled drugs may not reach levels that pose a significant risk for patients, the discovery of the contaminants has caused disruptions for patients across the globe.
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