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Torrent Pharma issues voluntary nationwide recall of Losartan Potassium tablets: USFDA


Torrent Pharma issues voluntary nationwide recall of Losartan Potassium tablets: USFDA

New Delhi: Indian pharmaceutical major, Torrent Pharmaceuticals Limited is voluntarily recalling 2 lots of Losartan potassium tablets in the US market used due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited.

The impurity detected in the API is N-nitrosodiethylamine (NDEA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification.

To date, Torrent Pharmaceuticals Limited has not received any reports of adverse events related to this recall.

Losartan is used to treat hypertension, hypertensive patients with Left Ventricular Hypertrophy and for the treatment of nephropathy in Type 2 diabetic patients. Patients who are on Losartan should continue taking their medication, as the risk of harm to the patient’s health may be higher if the treatment is stopped immediately without any alternative treatment. Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication.

The products subject to recall are listed below and packaged in bottles. The product can be identified by checking the product name, manufacturer details and batch or lot number on the bottle containing these products.

NDC Manufacturer Product Description Lot/Batch Expiration Date
13668-
115-30
Torrent
Pharmaceuticals LTD
LOSARTAN POTASSIUM TAB, USP 100mg,30count bottles BO31C016 04/2019
13668-
115-90
Torrent
Pharmaceuticals LTD
LOSARTAN POTASSIUM TAB, USP 100mg,90count bottles BO31C016 04/2019
13668-
115-10
Torrent
Pharmaceuticals LTD
LOSARTAN POTASSIUM TAB, USP
100mg,1000-count bottles
4DK3C005 04/2019

Losartan potassium tablets, USP were distributed nationwide to Torrent’s wholesale distributor, repackager and retail customers. Torrent Pharmaceuticals Limited is notifying its distributors and customers by phone and in writing to immediately discontinue distribution of the specific lots being recalled and to notify their sub-accounts. Torrent is arranging for return of all recalled products to Qualanex. Instructions for returning recalled products are given in the recall 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 8:00 am – 5:00 pm Eastern Time, voicemail available 24 hours/day, 7 days/week).
  • Medinfo.Torrent@apcerls.com

Consumers should also contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Any general questions regarding the return of this product should be directed to Qualanex at 1-888-280-2040 (live calls received 8 am – 9:00 pm Eastern Time). Adverse reactions or quality problems associated with the use of this product may be reported to FDA’s MedWatch Adverse Event Reporting program either by phone, online, by regular mail or by fax.

  • Complete and submit the report Online: www.fda.gov/medwatch/report.htm
  • Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Also Read: Torrent Pharma Q2 net profit dips 12 percent to Rs 179 crore

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Farhat Nasim

Farhat Nasim

Farhat Nasim joined Medical Dialogue as Reporter in 2017. She Covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She is a graduate of St.Xavier's College Ranchi. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751


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