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It may sound like a broken record at this point, but another company is reminiscent of a blood pressure drug and heart after discovering a carcinogenic ingredient.
This time, Legacy Pharmaceutical Packaging extends the recall of a batch of repackaged Losartan tablets.
According to the United States Food and Drug Administration (FDA), on April 24, traces of the potentially cancer-related chemical, NMBA, have been discovered. The agency described this as a "process impurity or possible contaminant".
The package recalled (FDA)Legacy prepares bulk pharmaceuticals from drug manufacturers and delivers the finished products to retailers, USA Today reported. The report indicates that it was sent to Kroger, who did not issue a statement on the recall.
Legacy, according to the FDA, has not received any adverse drug reactions related to the recall.
Losartan Potassium USP has been recalled and used to treat high blood pressure and congestive heart failure.
The drug is packaged in vials of 30 tablets bearing the NDC identification number NDC 68645-494-54. More details on the drug are available on the FDA website.
The tablet belonging to the recalled batch (FDA)"Losartan potassium has been distributed by the country's pharmacies. Legacy Pharmaceutical Packaging LLC advises its distributors and customers in writing and arranges / assists in the return of all recalled products to Inmar Pharmaceutical Services. Instructions for returning the recalled products are provided in the recall letter, "the FDA said in a statement.
For a list of other losartan recalls, the FDA website contains details.
For a list of valsartan recalls until March 1, the FDA website contains details.
For a list of irbesartan recalls until March 1st, the FDA website contains details.
FDA update
Several weeks ago, the FDA released a list of blood pressure medications that can be used safely, which means they do not contain nitrosamine.
On April 5, the agency released a list of about 40 drugs for the treatment of hypertension and heart where nitrosamine, related to cancer, is "absent".
In this undated photo, the FDA has expanded the reminder of valsartan, which is found in certain drugs intended for heart treatment and high blood pressure. (NTD TV screen capture)The problem appeared in July 2018, when the FDA announced that she had recalled several drugs containing valsartan after the discovery of impurities. These drugs were manufactured by a drug manufacturer in China.
Since then, the FDA "has been working hard to understand how this problem has arisen, how we could treat and mitigate exposure to this unnecessary risk to patients and what we could do to prevent these types of impurities from occurring. reproduce in future drugs, "according to the newspaper. to a press release of April 4th.
The statement from the health agency adds that the presence of nitrosamines is "not acceptable" in drugs.
This photo taken on March 14 shows a Chinese policeman crossing a pile of fake drugs seized in Beijing. (STR / AFP / Getty Images)"We also continue to work with manufacturers to quickly remove drugs from the market if they contain a nitrosamine impurity at levels above the acceptable intake limits. The removal of the relevant drugs from the market has resulted in shortages, and since then, we have been working to mitigate and prevent shortages as often as possible, "the agency said.
Common nitrosamines include N, N-dimethylnitrosamine (NDMA), N, N-diethylnitrosamine (NDEA), 4- (methylnitrosamino) -1- (3-pyridyl) -1-butanone (NNK).
The list of 40 "safe" drugs can be found on the FDA website.
For drugs marked "not present", this means that the FDA "has completed the complete assessment noted above".
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