Blood Pressure Medication Recall 2019: Another Recall For Cancer Causing Impurity

After several recalls by Torrent Pharmaceuticals Limited (TORNTPHARM.NS) for its Losartan Potassium blood pressure medication because it may have the potential to cause cancer, the company is again expanding the recall to include even more lots of Losartan Potassium tablets USP and Losartan Potassium/Hydrochlorothiazide tablets because they may also have the potential to cause cancer.

Torrent Pharmaceuticals expanded the recall because its blood pressure medication may have trace amounts of an unexpected impurity - N-Methylnitrosobutyric acid (NMBA). The NMBA levels detected in the medication were above the daily intake levels approved by the U.S. Food and Drug Administration (FDA).

The affected blood pressure medication is used in the treatment of hypertension, hypertensive patients with Left Ventricular Hypertrophy or to treat nephropathy in Type 2 diabetic patients.

The recalled blood pressure medication was manufactured by Hetero Labs Limited and includes three additional lots of Losartan Potassium tablets USP and two additional lots of Losartan Potassium/hydrochlorothiazide tablets, USP. The pressure medication was distributed nationwide to retail customers, repackagers, and wholesale distributors.

The recalled blood pressure medication that is part of the now expanded recall includes:

• 50 mg of Losartan Potassium tablets, USP in 1000 count bottles with an NDC code of 13668-409-10, a batch number of 4DU2E009, and an expiration date of 12/31/2020 located on the label of the bottle.
• 100 mg of Losartan Potassium tablets, USP in 90 count bottles with an NDC code of 13668-115-90, a batch number of 4DU3E009 and an expiration date of 12/31/2020 located on the label of the bottle.
• 100 mg of Losartan Potassium tablets, USP in 1000 count bottles with an NDC code of 13668-115-10, a batch number of 4DU3D018, and an expiration date of 02/28/2021 located on the label of the bottle.
• 50 mg/12.5 mg Losartan Potassium/Hydrochlorothiazide tablets, USP in 90 count bottles with an NDC code of 13668-116-90, a batch number of BEF7D051, and an expiration date of 11/30/2020 located on the label of the bottle.
• 100 mg/25 mg Losartan Potassium/Hydrochlorothiazide tablets, USP in 90 count bottles with an NDC code of 13668-118-90, a batch number of 4P04D007, and an expiration date of 07/31/2020 located on the label of the bottle.

Consumers that have medical questions about the recall or are reporting adverse effects from the recalled medication should contact Torrent Pharmaceuticals at 1-800-912-9561 from 8 a.m. to 5 p.m. ET or by emailing Medinfo.Torrent@apcerls.com. Voicemail is available 24 hours a day, seven days a week.

General question about returning the recalled blood pressure medication can be directed to Qualanex at 1-888-280-2040, from 8 a.m. to 9 p.m. ET.

Patients that have been prescribed the recalled blood pressure medication should continue to take the tablets as the risk of stopping treatment without an alternative medication could be higher than continuing to take the affected Losartan tablets.

Patients should, however, contact their pharmacist or physician for an alternative treatment plan. Consumers that experience problems with taking the affected medication should contact their healthcare provider.

Shares of Torrent Pharmaceuticals stock were up 1.47 percent as of 10:17 a.m. ET on Friday.