Update: Torrent Pharmaceuticals Limited Extends Voluntary National Booster of Losartan Potassium Tablets, USP and Losartan Potassium / Hydrochlorothiazide Tablets, USP

Summary

Business Announcement

Torrent Pharmaceuticals Limited expands the recall of Losartan Potassium Tablets USP and Losartan Potassium / Hydrochlorothiazide Tablets, USP, due to the detection of traces of an unexpected impurity when testing batches of finished products below manufactured at using active ingredient) manufactured by Hetero Labs Limited using the old Route of Synthesis. The recall is extended to include 3 additional lots of losartan potassium USP tablets and 2 batches of Losartan potassium and hydrochlorothiazide tablets, USP.

The impurity detected is N-methylnitrosobutyric acid (NMBA). Torrent only recalls batches of products containing losartan containing N-methylnitrosobutyric acid (NMBA) above the acceptable daily intake levels published by the FDA.

Losartan is used to treat hypertension, hypertensive patients with left ventricular hypertrophy and treatment of nephropathy in patients with type 2 diabetes. Losartan Potassium and Hydrochlorothiazide Tablets, USP are used to treat lymphatic disease. hypertension and hypertensive patients with left ventricular hypertrophy.

Patients taking Losartan Potassium Tablets, USP and Losartan Potassium / Hydrochlorothiazide Tablets, USP should continue taking their medications because the risk of harm to the patient's health may be higher if the treatment is stopped immediately without further treatment. Patients should contact their pharmacist or their treating physician, who can inform them of an alternative treatment before returning their medication.

The products / lots included in the extended recall are listed below. The product can be identified by verifying the product name, the manufacturer's details and the lot or lot number on the bottle containing these products.

Losartan Potassium Tablet and Lots of Losartan Potassium / Hydrochlorothiazide Tablet

Losartan Potassium Tablets, USP and Losartan Potassium / Hydrochlorothiazide Tablets, USP were distributed nationally to wholesale distributors in Torrent, repacking companies and retailers. Torrent Pharmaceuticals Limited advises its distributors and customers by telephone and in writing to immediately stop the distribution of the specific lots recalled and to notify their sub-accounts. Torrent organizes the return of all recalled products to Qualanex. The instructions for returning the recalled products are given in the reminder letter.

Consumers with medical questions regarding this recall or to report an adverse event can contact Torrent Pharmaceuticals Limited at:

• 1-800-912-9561 (live calls received from 8:00 am to 5:00 pm, Eastern Time, voicemail available 24 hours a day, 7 days a week).
• [email protected]

Consumers should also contact their doctor or health care provider if they have ever had problems that may be related to taking or using this drug product.

All general questions about the return of this product should be directed to Qualanex at 1-888-280-2040 (live calls received from 8:00 am to 9:00 pm Eastern Time).

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Events Reporting Program, online, by post or by fax.

Complete and submit the report Online: www.fda.gov/medwatch/report.htm
Ordinary mail or fax: Download Form www.fda.gov/MedWatch/getforms.htm
Call 1-800-332-1088 to request a report form, then complete and return to the address on the pre-addressed form, or fax it to 1-800-FDA-0178

This recall is made with the knowledge of the US Food and Drug Administration.

Link to the original reminder
Link to the first extension reminder
Link to the second recall of expansion
Link to the 3rd extension reminder
Link to the 4th extension reminder