Torrent Pharmaceuticals Recalls Its Blood Pressure Medications

Torrent Pharmaceuticals announced that it is expanding its recall of blood pressure medications after more testing revealed trace amounts of a known human carcinogen.

 

The recall is voluntary, said the company. Yesterday, it added five lots of the generic drug losartan to an April recall of more than 100 lots of the same medications. The lots were all contained N-methylnitrosobutyric acid (NMBA) above the acceptable daily intake levels. These levels were set by the U.S. Food and Drug Administration (FDA).

 

While there is concern, both Torrent and the FDA recommend that patients continue to take this medicine until an alternative medication can be found. They expect to have a substitute in place very soon.

 

In the meantime, the FDA cautions that not taking the medication is a greater risk to patients health compared to waiting a bit longer for the substitute.

 

Right now, patients should call their doctor — and get a recommendation for a short-term alternative medicine.

 

 

 

Torrent Pharmaceuticals: What Happened?

How did a human carcinogen get into Torrent’s blood pressure medicine?

 

The answer can be traced back to the FDA. They started testing all heart drugs for impurities after July 2018. At that time, traces of the carcinogen N-nitrosodimethylamine (NDMA) were found in blood pressure medications  that contained valsartan. This carcinogen was supplied by a Chinese company.

 

If you’re currently taking Losartan — or know someone who is, call your doctor immediately.

 

Below is the manufacturer’s list of recalled Losartan versions. If you have any one of these products, let your doctor know right away.

The lots include:

• Losartan Potassium Tablets, USP 50mg, 1,000 count (National Drug Code 13668-409-10; Batch Number 4DU2E009; Expiration Date 12/31/2020)
• Losartan Potassium Tablets, USP 100mg, 90 count (National Drug Code 13668-115-90; Batch Number 4DU3E009; Expiration Date 12/31/2020)
• Losartan Potassium Tablets, USP 100mg, 1,000 count (National Drug Code 13668-115-10; Batch Number 4DU3E018; Expiration Date 02/28/2021)
• Losartan Potassium/Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 count (National Drug Code 13668-116-90; Batch Number BEF7D051; Expiration Date 11/30/2020)
• Losartan Potassium/Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count (National Drug Code 13668-118-90; Batch Number 4P04D007; Expiration Date 07/31/2020)