The Food and Drug Administration has issued another warning about possible impurities in common drugs used to treat acid reflux and high blood pressure.
Only certain lots of the drugs are affected.
Ranitidine tablets, the generic form of the over-the-counter antihistamine/antacid Zantac, are the latest to be recalled. Specific lots of the drug have been found to contain low-levels of N-nitrosodimethylamine, a chemical classified as a possible cancer-causing agent in humans, based on laboratory tests.
In a Sept. 13 memo, the FDA said it is not calling for people to stop taking ranitidine but it advised that people could consider other OTC medicines approved for the same use.
Apotex Corp. announced Wednesday that it is voluntarily recalling 75mg and 150mg pills in all packs and sizes to the retail level. The affected pills were sold as acid reducers and packaged under the Rite Aid, Walmart and Walgreens store labels. They were distributed nationwide.
Wholesalers, distributors and retailers have been asked to ensure the affected product isn’t sold and return it to where it was purchased.
Customers who bought the affected product directly from Apotex can call Inmar Rx Solutions at 800-967-5952 to arrange for its return.
The FDA has also issued multiple warnings this year about blood pressure medication sold under the names losartan, valsartan and irbesartan due to the same types of contaimination. In a Sept. 13 update, the FDA said it has been investigating low-level NDMAand other nitrosimine impurities in blood pressure and heart failure medicines called AngiotensinII Receptor Blockers since last year.
It has recommended numerous recalls as unacceptable levels of nitrosamines were discovered in those drugs.
The FDA says people should not suddenly stop taking their medication because that could cause serious health problems. They should contact their doctor or pharmacist with concerns and requests for substitutions.
“It also is important to know that not all ARBs contain NDMA or NDEA, so pharmacists may be able to provide a refill of medication not affected by the recall, or doctors may prescribe a different medication that treats the same condition,” the agency wrote.
USA Today reported that the contaminants found in the medications likely resulted from a manufacturing change at the factories in China and India that make the drug ingredients.
“In January, the agency admitted that some versions of the drug valsrtan contained trace amounts of a carcinogen for four years before regulators detected the impurity last summer,” according to an article published Monday.
A complete listing of FDA recall notices can be found at fda.gov/safety/recalls-market-withdrawals-safety-alerts.