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How FDA drug recalls work
The US Food and Drug Administration regulates drug safety, but a problem can sometimes trigger a recall. Here's how the reminder process works and what you need to do if a medicine you use is recalled.
The US Food and Drug Administration regulates drug safety, but a problem can sometimes trigger a recall. Here's how the reminder process works and what you need to do if a medicine you use is recalled.
Losartan, a drug for the treatment of high blood pressure and high blood pressure, has been recalled from 35 other batches due to the presence of unsafe amounts of NMBA in the active ingredient.
Teva Pharmaceuticals has manufactured Losartan Potassium USP Tablets at 25 mg and 100 mg for Golden State Medical Supply, according to the recall notice issued by Teva and the FDA. Golden State then repackages the tablets for retail sale. The Golden State website identifies his company's customers as mail order pharmacies, military pharmacies, and local or federal governments.
As Torrent and Camber did during their recent recall of losartan on NMBA (nitroso-N-methyl-4-aminobutyric acid), Teva is pointing fingers at Hetero Labs Limited. Teva says that six batches of the active ingredient in losartan, from Hetero Labs, had an NMBA higher than the FDA's recommendations.
"Based on the available information, the risk of developing cancer in a few patients after long-term use of the product can not be ruled out," says the recall notice.
The FDA recommends that anyone with losartan, valsartan or recalled irbesartan continue to take this medicine until your doctor or pharmacist offers a new treatment. If you do not take the necessary medications, you will be more likely to be injured in the short term.
The 25 mg tablets are light green in color with a form of water drop, "LK 25" on one side and a ">" sign on the other side. The 100 mg tablets are dark green and oval with the symbols "LK100" and ">" on the sides.
To check the lot numbers after repackaging Golden State Medical, click here.
Until last week, the FDA was keeping the lists of losartan, valsartan and irbesartan recalled, but it inexplicably narrowed its list to one page stating that it was not updated since March 13th.
For customers who wish to return their tablets, contact Teva Inmar Recall Processing at 877-789-2065 Monday to Friday from 9:00 am to 5:00 pm (Eastern Time) or by email at the address [email protected]. Golden State Medical Supply customers can call 800-284-8633, ext. 215, fax 805-437-7582 or by email at the address [email protected]
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