The recall comes after research discovered that batches of the drug contained elevated levels of nitrosamine, a cancer-causing agent. It was announced on March 22 and consists of five batches of pills, each with 90 bottles.
Pfizer believes the bottles were split into smaller prescriptions and has urged any doctor or pharmacist who dealt with the shipments in question to contact them immediately.
According to a Pfizer news release, the drugs were distributed in the United States and Puerto Rico between December 2019 and April 2022. Pfizer described the recall as ‘voluntary’ in its statement.
The bottles contain 90 pills and are prescribed in increments of 10mg, 20mg, and 40mg. The number of pills in each bottle can be divided into smaller amounts.
Pfizer had already announced a similar recall in Canada after the same impurity was found to be above acceptable levels.
According to a Canadian government statement, people who consume nitrosamine at an acceptable level or lower for 70 years are ‘not expected to have an increased risk of cancer.’
In announcing the recall, the company stated that it had received no reports of specific incidents involving the drug.
The company also stated that there is no immediate danger to patients who are already taking the medication.
Nitrosamines are found in a variety of foods, including cured and grilled meats, dairy products, and vegetables.
Everyone is exposed to nitrosamines in some way, and the risk of cancer is only associated with long-term high-level exposure.
Accupril works by decreasing the chemicals that cause blood vessels to constrict. This improves blood flow and allows the heart to work more efficiently.
Muscle and joint pain, sensitivity to light, a dry cough, and dizziness are common side effects of the medication.
According to Pfizer, it is also approved to treat heart failure as an add-on therapy to medications such as diuretics or digitalis.
Pfizer has had a history of recalls due to N-nitrosodimethylamine, known as NDMA, and nitrosamine contamination, but the biggest issues were with Chantix, its anti-smoking medication, throughout 2021 as Endpoints News reports.
The pharmaceutical company halted the anti-smoking drug’s global distribution at the consumer level due to impurities.
The FDA website includes information about nitrosamine impurities for five drugs: Chantix, Zantac, Metformin, Losartan/Valsartan, and Rifampin/Rifapentine.
However, the company is not alone in its difficulties. Viona Pharmaceuticals recalled 33 lots of metformin hydrochloride in January after discovering NDMA in two batches the previous June. In 2020, Nostrum Laboratories recalled its generic metformin twice.