YOUNGSTOWN, Ohio (WKBN) – Torrent Pharmaceuticals has expanded a voluntary recall of some blood pressure medications.
The recall expansion includes Losartan Potassium Tablets USP and Losartan Potassium/hydrochlorothiazide tablets, USP.
According to the company, an impurity was detected while testing the medication and is now into the fifth expansion of the initial recall.
The impurity is N-Methylnitrosobutyric acid (NMBA)., which has been linked to cancer.
Torrent is only recalling lots that contain NMBA above the acceptable daily intake levels released by the FDA.
The recall is expanded to include an additional three lots of Losartan:
Potassium Tablets USP and 2 lots of Losartan
Potassium/Hydrochlorothiazide Tablets, USP
Losartan Potassium Tablet and Losartan Potassium / Hydrochlorothiazide Tablet Lots
| NDC | Product Name, Strength and Package Count | Batch Number | Expiration Date |
|---|---|---|---|
| 13668-409-10 | Losartan Potassium Tablets, USP 50mg, 1000 count | 4DU2E009 | 12/31/2020 |
| 13668-115-90 | Losartan Potassium Tablets, USP 100mg, 90 count | 4DU3E009 | 12/31/2020 |
| 13668-115-10 | Losartan Potassium Tablets, USP 100mg, 1000 count | 4DU3E018 | 02/28/2021 |
| 13668-116-90 | Losartan Potassium / Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 count | BEF7D051 | 11/30/2020 |
| 13668-118-90 | Losartan Potassium / Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count. | 4P04D007 | 07/31/2020 |
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 taking the medications are advised by the company to continue taking their medication, as the risk of harm may be higher if the treatment is stopped without alternative treatment.
Patients should contact their doctor and pharmacist.
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