43 lots of drugs for heart and blood pressure have been recalled, according to the FDA



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Legacy Pharmaceutical Packaging has announced the voluntary recall of 43 batches of drugs used to treat congestive heart failure and high blood pressure, according to a press release issued March 15 by the FDA (Food and Drug Administration) to United States.

The company recalls Losartan potbadium tablets after two other pharmaceutical companies, Camber Pharmaceuticals and Torrent Pharmaceuticals, recalled drugs after discovering traces of NBMA. The tablets were manufactured by Hetero Labs.

According to the Miami Herald, Torrent and Camber provided Legacy. NBMA is a possible carcinogen for humans.

RECALL ALERT: If you are taking this medicine, tell your doctor.

Her Miami Herald 于 2019 3 16 周六

Legacy said she remembered three lots of Losartan bottles of 50 milligrams and 30 units, manufactured by Torrent and distributed by Kroger. According to Herald magazine, Camber has manufactured another 40 50 mg and 100 mg tablets sold in bottles of 30 tablets.

"The product can be identified by checking the product name and reconditioned lot number on the bottle containing these products," the FDA said.

Legacy has not received any reports of adverse events related to the recall.

At the head of: check your medications for any of these 43 batches shipped nationwide!

Channel AF WAFB Channel 9 年 月 2019 年 3 16 日

The FDA has previously stated that consumers recalling medications should continue to take them and should ask their pharmacist or doctor if they wish to stop or change medication. This includes valsartan, losartan or irbesartan.

For a list of other losartan recalls, the FDA website contains details.

For a list of valsartan recalls until March 1st, the FDA website contains details.

For a list of irbesartan recalls until March 1, the FDA website contains details.

Camber Reminder

Another pharmaceutical company said that she was recalling high blood pressure and heart medication after finding traces of a carcinogenic chemical.

Camber Pharmaceuticals has announced the recall of 87 batches of losartan tablets, including 25 mg, 50 mg and 100 mg, according to a notice posted on the FDA's website (Food and Drug Administration).

A trace amount of N-Nitroso N-methyl-4-aminobutyric acid (NMBA) was found in batches. Health officials have described NMBA as a potential carcinogen to humans.

The FDA has stated that the chemical has entered the batches via a treatment impurity or via an ingredient manufactured by a third-party manufacturer.

valsartan reminder drug fda
In this undated photo, the FDA has expanded the reminder of valsartan, which is found in some medicines intended for heart treatment and hypertension. (Screen Capture / NTD TV)

FDA warning about scarcity

Last month, the FDA issued a warning about a drug shortage for blood pressure caused by recalls.

"Valsartan products are in short supply and we know that other types of products may be coming soon," said FDA Commissioner Scott Gottlieb and the director of drug evaluation and drug research. FDA, Janet Woodbad.

In July, the FDA conducted laboratory tests on drugs containing valsartan made by a Chinese company and discovered the presence of NDMA and NDEA. According to the Environmental Protection Agency, NDMA is found in rocket fuels, lubricants and other additives.

"Both of these substances are known environmental contaminants and are found in water and food, including meat, dairy products and vegetables. But their presence in pharmaceuticals is not acceptable, "said the FDA at the time.

The problem appeared in the summer of 2018 after the FDA had learned that an active ingredient manufactured by Zhejiang Huahai Pharmaceutical Co. Ltd. in Linhai, China, contained NDMA.

"We also sent them a warning letter describing several violations of the manufacturing process, including checking for impurities, checking for changes, and cross-contamination from one production line to another," the report said. FDA release last month.

After an investigation into Zhejiang's manufacturing process, the FDA discovered a change that could lead to the introduction of carcinogenic chemicals. The impurity has also not been detected by global health agencies, including the FDA, until last summer.

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