(Credit: Torrent Pharmaceuticals via FDA)
Torrent Pharmaceuticals Limited is voluntarily recalling two lots of Losartan potassium tablets, USP to the consumer level 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 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. The company 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).
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).
The recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
(Source: U.S. Food and Drug Administration)
