Torrent Pharmaceuticals Limited is expanding its recall for Losartan Potassium Tablets USP and Losartan Potassium / hydrochlorothiazide tablets, USP, to the consumer level due to the detection of trace amounts of an unexpected impurity while testing in certain finished product batches manufactured utilizing active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited using the old Route of Synthesis, according to the U.S. Food and Drug Administration.
The recall is expanded to include an additional 3 lots of Losartan Potassium Tablets USP and 2 lots of Losartan Potassium/Hydrochlorothiazide Tablets, USP.
The impurity detected is N-Methylnitrosobutyric acid (NMBA) and Torrent is only recalling lots of losartan-containing products that contain N-Methylnitrosobutyric acid (NMBA) above the acceptable daily intake levels released by the FDA.
Losartan is used to treat hypertension, hypertensive patients with Left Ventricular Hypertrophy and for the treatment of nephropathy in Type 2 diabetic patients. Losartan Potassium and Hydrochlorothiazide tablets, USP is used to treat hypertension and hypertensive patients with Left Ventricular Hypertrophy.
Patients who are taking Losartan Potassium Tablets, USP and Losartan Potassium / Hydrochlorothiazide Tablets, USP 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 product can be identified by checking the product name, manufacturer details and batch or lot number on the bottle containing these products.
Here are the lots you should look for:
Losartan Potassium Tablets, USP 50mg, 1000 count
- NDC: 13668-409-10
- Batch No.: 4DU2E009
- Expiration: 12/31/2020
Losartan Potassium Tablets, USP 100mg, 90 count
- NDC: 13668-115-90
- Batch No.: 4DU3E009
- Expiration: 12/31/2020
Losartan Potassium Tablets, USP 100mg, 1000 count
- NDC: 13668-115-10
- Batch No.: 4DU3D018
- Expiration: 02/28/2021
Losartan Potassium / Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 count
- NDC: 13668-116-90
- Batch No.: BEF7D051
- Expiration: 11/30/2020
Losartan Potassium / Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count
- NDC: 13668-118-90
- Batch No.: 4P04D007
- Expiration: 07/31/2020
Losartan Potassium tablets, USP and Losartan Potassium/ Hydrochlorothiazide 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) or via email at 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 8:00 a.m. – 9:00 p.m. Eastern Time).