subscribe: Posts | Comments

leader

Updated: Torrent Pharmaceuticals Limited Expands Voluntary Nationwide Recall of Losartan Potassium Tablets, USP and Losartan Potassium/Hydrochlorothiazide Tablets, USP

0 comments
Updated: Torrent Pharmaceuticals Limited Expands Voluntary Nationwide Recall of Losartan Potassium Tablets, USP and Losartan Potassium/Hydrochlorothiazide Tablets, USP

For Immediate Release

April 18, 2019

Contact

Consumers

 1-800-912-9561
 Medinfo.Torrent@apcerls.com

Announcement

View Product Photos

Torrent Pharmaceuticals Limitedis expanding its recall for Losartan Potassium Tablets USP and Losartan Potassium/hydrochlorothiazide tablets, USP, to theconsumerlevel due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited.

The Recall is expanded to include an additional 36 lots of Losartan potassium Tablets USP and 68 lots of Losartan Potassium/Hydrochlorothiazide Tablets, USP

The impurity detected in the API is N-Methylnitrosobutyric acid (NMBA). 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.

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. 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/lots included in the expanded recall are listed below in red.The product can be identified bychecking the product name, manufacturer details and batch or lot number on the bottle containing these products.

Losartan Potassium Tablet and Losartan Potassium/ Hydrochlorothiazide Tablet Lots

NDCFinished Product Strength and Package CountBatch NumberExpiration Date
13668-113-90Losartan Potassium Tablets, USP 25mg, 90 count4DU1E0051/31/2021
13668-113-90Losartan Potassium Tablets, USP 25mg, 90 count4DU1E0061/31/2021
13668-113-90Losartan Potassium Tablets, USP 25mg, 90 count4DU1E0081/31/2021
13668-113-10Losartan Potassium Tablets, USP 25mg, 1000 count4DU1E0071/31/2021
13668-409-30Losartan Potassium Tablets, USP 50mg, 30 count4DU2D07710/31/2020
13668-409-90Losartan Potassium Tablets, USP 50mg, 90 count4DU2D08710/31/2020
13668-409-90Losartan Potassium Tablets, USP 50mg, 90 count4DU2E0231/31/2021
13668-409-90Losartan Potassium Tablets, USP 50mg, 90 count4DU2E0241/31/2021
13668-409-90Losartan Potassium Tablets, USP 50mg, 90 count4DU2E0261/31/2021
13668-409-90Losartan Potassium Tablets, USP 50mg, 90 count4DU2E0271/31/2021
13668-409-90Losartan Potassium Tablets, USP 50mg, 90 count4DU2E0281/31/2021
13668-409-90Losartan Potassium Tablets, USP 50mg, 90 count4DU2E0291/31/2021
13668-409-90Losartan Potassium Tablets, USP 50mg, 90 count4DU2E0201/31/2021
13668-409-90Losartan Potassium Tablets, USP 50mg, 90 count4O50E0078/31/2021
13668-409-90Losartan Potassium Tablets, USP 50mg, 90 count4O50E0088/31/2021
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2D0679/30/2020
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2D0699/30/2020
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2D0639/30/2020
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2D0649/30/2020
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2D0659/30/2020
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2D0669/30/2020
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2D08410/31/2020
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2D08510/31/2020
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2D08310/31/2020
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2D08210/31/2020
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2D07210/31/2020
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2D07710/31/2020
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2D07810/31/2020
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2D07910/31/2020
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2D08110/31/2020
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2D08010/31/2020
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2D07010/31/2020
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2D07310/31/2020
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2D07410/31/2020
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2D07510/31/2020
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2D08610/31/2020
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2D08810/31/2020
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2D08910/31/2020
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2E0191/31/2021
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2E0211/31/2021
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2E0221/31/2021
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2E0251/31/2021
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2E0322/28/2021
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2E0332/28/2021
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2E0342/28/2021
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2E0352/28/2021
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2E0362/28/2021
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2E0372/28/2021
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2E0382/28/2021
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2E0392/28/2021
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2E0412/28/2021
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2E1036/30/2021
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2E1016/30/2021
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2E1026/30/2021
13668-115-90Losartan Potassium Tablets, USP 100mg, 90 count4DU3E0141/31/2021
13668-115-90Losartan Potassium Tablets, USP 100mg, 90 count4DU3E0151/31/2021
13668-115-90Losartan Potassium Tablets, USP 100mg, 90 count4DU3E0657/31/2021
13668-115-10Losartan Potassium Tablets, USP 100mg, 1000 count4DU3D01811/30/2020
13668-115-10Losartan Potassium Tablets, USP 100mg, 1000 count4DU3E0626/30/2021
13668-115-10Losartan Potassium Tablets, USP 100mg, 1000 count4DU3E0636/30/2021
13668-116-30Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 30 countBEF7D0176/30/2020
13668-116-90Losartan Potassium /Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 countBEF7D0104/30/2020
13668-116-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 countBEF7D0114/30/2020
13668-116-90Losartan Potassium /Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 countBEF7D0186/30/2020
13668-116-90Losartan Potassium / Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 countBEF7D0094/30/2020
13668-116-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 count4P02E0021/31/2021
13668-116-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 count4P02E0031/31/2021
13668-116-90Losartan Potassium / Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 count4P02E0041/31/2021
13668-116-10Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 1000 countBEF7D0084/30/2020
13668-116-10Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 1000 countBEF7D0228/31/2020
13668-116-10Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 1000 countBEF7D0124/30/2020
13668-116-10Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 1000 countBEF7D0134/30/2020
13668-116-10Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 1000 countBEF7D04911/30/2020
13668-116-10Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 1000 count4P02E0051/31/2021
13668-116-10Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 1000 count4P02E0061/31/2021
13668-117-30Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 30 countBEF8D05811/30/2020
13668-117-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 countBEF8D0234/30/2020
13668-117-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 countBEF8D0244/30/2020
13668-117-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 countBEF8D0254/30/2020
13668-117-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 countBEF8D0093/31/2020
13668-117-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 countBEF8D0103/31/2020
13668-117-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 countBEF8D0113/31/2020
13668-117-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 countBEF8D0123/31/2020
13668-117-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 countBEF8D0133/31/2020
13668-117-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 countBEF8D05410/31/2020
13668-117-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 countBEF8D05510/31/2020
13668-117-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 countBEF8D05610/31/2020
13668-117-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 countBEF8D05711/30/2020
13668-117-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 countBEF8D0073/31/2020
13668-117-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 countBEF8D0083/31/2020
13668-117-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 countBEF8D0204/30/2020
13668-117-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 countBEF8D0214/30/2020
13668-117-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 countBEF8D0224/30/2020
13668-118-30Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 30 countBEF6D0384/30/2020
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 countBEF6D0304/30/2020
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 countBEF6D0314/30/2020
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 countBEF6D0477/31/2020
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90countBEF6D0487/31/2020
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 countBEF6D0497/31/2020
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 countBEF6D0507/31/2020
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 countBEF6D0517/31/2020
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 countBEF6D08210/31/2020
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 countBEF6D08310/31/2020
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 countBEF6D08410/31/2020
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 countBEF6D08510/31/2020
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 countBEF6D08610/31/2020
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 countBEF6D08710/31/2020
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count4P04E0031/31/2021
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count4P04E0041/31/2021
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count4P04E0051/31/2021
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count4P04E0061/31/2021
13668-118-10Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 1000 count4P04E0071/31/2021
13668-118-10Losartan Potassium/Hydrochlorothiazide Tablets, USP 100mg/25mg, 1000 count4P04E0081/31/2021
13668-118-10Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 1000 count4P04E0091/31/2021
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 countBEF6D0517/31/2020
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 countBEF6D08210/31/2020
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 countBEF6D08310/31/2020
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 countBEF6D08410/31/2020
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 countBEF6D08510/31/2020
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 countBEF6D08610/31/2020
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 countBEF6D08710/31/2020
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count4P04E0031/31/2021
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count4P04E0041/31/2021
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count4P04E0051/31/2021
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count4P04E0061/31/2021
13668-118-10Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 1000 count4P04E0071/31/2021
13668-118-10Losartan Potassium/Hydrochlorothiazide Tablets, USP 100mg/25mg, 1000 count4P04E0081/31/2021
13668-118-10Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 1000 count4P04E0091/31/2021
13668-113-90Losartan Potassium Tablets, USP 25mg, 90 countBDK1C0037/31/2019
13668-113-10Losartan Potassium Tablets, USP 25mg, 1000 countBDK1C0027/31/2019
13668-113-10Losartan Potassium Tablets, USP 25mg, 1000 count4DU1D00412/31/2019
13668-113-10Losartan Potassium Tablets, USP 25mg, 1000 count4DU1D00512/31/2019
13668-113-10Losartan Potassium Tablets, USP 25mg, 1000 count4DU1D00612/31/2019
13668-409-90Losartan Potassium Tablets, USP 50mg, 90 count4DU2D00512/31/2019
13668-409-90Losartan Potassium Tablets, USP 50mg, 90 count4DU2D00612/31/2019
13668-409-90Losartan Potassium Tablets, USP 50mg, 90 count4DU2D0263/31/2020
13668-409-90Losartan Potassium Tablets, USP 50mg, 90 count4DU2D0273/31/2020
13668-409-90Losartan Potassium Tablets, USP 50mg, 90 count4DU2D0293/31/2020
13668-409-90Losartan Potassium Tablets, USP 50mg,90 count4DU2E00712/31/2020
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2D0408/31/2020
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2D0418/31/2020
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2D0428/31/2020
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2D0172/29/2020
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2D0253/31/2020
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2D0283/31/2020
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2D0458/31/2020
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2D0468/31/2020
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2D0478/31/2020
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2D0488/31/2020
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2E0422/28/2021
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 count4DU2E0442/28/2021
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 countBDK2E00112/31/2020
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 countBDK2E0128/31/2021
13668-409-10Losartan Potassium Tablets, USP 50mg, 1000 countBDK2E0138/31/2021
13668-115-90Losartan Potassium Tablets, USP 100mg, 90 count4DU3E0161/31/2021
13668-115-10Losartan Potassium Tablets, USP 100mg, 1000 count4DU3E0171/31/2021
13668-115-10Losartan Potassium Tablets, USP 100mg, 1000 count4DU3E0192/28/2021
13668-115-10Losartan Potassium Tablets, USP 100mg, 1000 count4DU3C0127/31/2019
13668-115-10Losartan Potassium Tablets, USP 100mg, 1000 count4DU3C0158/31/2019
13668-115-10Losartan Potassium Tablets, USP 100mg, 1000 count4DU3C0168/31/2019
13668-115-10Losartan Potassium Tablets, USP 100mg, 1000 count4DU3C0178/31/2019
13668-115-10Losartan Potassium Tablets, USP 100mg, 1000 count4DU3C0319/30/2019
13668-115-10Losartan Potassium Tablets, USP 100mg, 1000 count4DU3D0071/31/2020
13668-115-10Losartan Potassium Tablets, USP 100mg, 1000 count4DU3D0081/31/2020
13668-116-30Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 30 countBP02D00512/31/2019
13668-116-30Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 30 countBP02C05110/31/2019
13668-116-30Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 30 countBEF7D04711/30/2020
13668-116-90Losartan Potassium /Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 countBP02D00612/31/2019
13668-116-90Losartan Potassium /Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 countBP02D00712/31/2019
13668-116-90Losartan Potassium /Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 countBP02D0121/31/2020
13668-116-90Losartan Potassium /Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 countBEF7D0033/31/2020
13668-116-90Losartan Potassium /Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 countBP02C05010/31/2019
13668-116-90Losartan Potassium /Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 countBEF7D0268/31/2020
13668-116-90Losartan Potassium /Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 countBEF7D0278/31/2020
13668-116-90Losartan Potassium /Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 countBEF7D0288/31/2020
13668-116-90Losartan Potassium /Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 countBEF7D04511/30/2020
13668-116-90Losartan Potassium /Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 countBEF7D04611/30/2020
13668-116-90Losartan Potassium /Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 countBEF7E0051/31/2021
13668-116-10Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 1000 countBEF7D0053/31/2020
13668-116-10Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 1000 countBEF7D0298/31/2020
13668-116-10Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 1000 countBEF7D0308/31/2020
13668-116-10Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 1000 countBEF7D04811/30/2020
13668-116-10Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 1000 countBEF7E00112/31/2020
13668-116-10Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 1000 countBEF7E00212/31/2020
13668-116-10Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 1000 countBEF7E00312/31/2020
13668-116-10Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 1000 countBEF7E00412/31/2020
13668-116-10Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 1000 countBP02C05110/31/2019
13668-116-10Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 1000 countBP02C05210/31/2019
13668-117-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 countBEF8D06011/30/2020
13668-117-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 countBEF8D06111/30/2020
13668-117-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 countBEF8D06211/30/2020
13668-117-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 countBEF8D06311/30/2020
13668-117-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 countBX35D0241/31/2020
13668-117-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 countBEF8D06411/30/2020
13668-117-10Losartan Potassium /Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 1000 countBEF8D05911/30/2020
13668-117-10Losartan Potassium /Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 1000 countBEF8E0041/31/2021
13668-117-10Losartan Potassium /Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 1000 countBEF8E0051/31/2021
13668-118-30Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 30 countBEF6D0548/31/2020
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 countBEF6D10011/30/2020
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 countBEF6D10111/30/2020
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 countBEF6D10211/30/2020
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 countBEF6E00112/31/2020
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 countBEF6E00212/31/2020
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 countBEF6E00312/31/2020
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 countBEF6E00412/31/2020
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 countBEF6E00812/31/2020
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 countBEF6E00912/31/2020
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 countBEF6E01012/31/2020
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 countBEF6E01112/31/2020
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 countBEF6E01212/31/2020
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 countBP04D01212/31/2019
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 countBP04D01312/31/2019
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 countBP04C09210/31/2019
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 countBEF6D0123/31/2020
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 countBEF6D0133/31/2020
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 countBEF6D0609/30/2020
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 countBEF6D0619/30/2020
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 countBEF6D0639/30/2020
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 countBEF6D07610/31/2020
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 countBEF6D07710/31/2020
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 countBEF6D07810/31/2020
13668-118-90Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 countBEF6D07910/31/2020
13668-118-10Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 1000 countBP04C09410/31/2019
13668-118-10Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 1000 countBEF6D09611/30/2020
13668-118-10Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 1000 countBEF6D09711/30/2020
13668-118-10Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 1000 countBEF6D09811/30/2020
13668-118-10Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 1000 countBEF6D09911/30/2020
13668-118-10Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 1000 countBEF6E00512/31/2020
13668-118-10Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 1000 countBEF6E00612/31/2020
13668-118-10Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 1000 countBP04D0162/29/2020
13668-118-10Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 1000 countBP04D0172/29/2020
13668-118-10Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 1000 countBP04D0182/29/2020

Torrent Pharmaceuticals Limitedis expanding its recall for Losartan Potassium Tablets USP and Losartan Potassium/hydrochlorothiazide tablets, USP, to theconsumerlevel due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited.

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).
  • 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 experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report Onlinewww.fda.gov/medwatch/report.htm

Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm

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

Link to Original Recall

Link to 1st Expansion Recall

Link to 2nd Expansion Recall

Link to 3rd Expansion Recall

###

Follow FDA

Product Photos

Image, losartan potassium tablet 25 mg
Image, losartan potassium tablet 50 mg
Image, losartan potassium tablet 100 mg
Green/White Label, Losartan potassium tablets, 25 mg, 90 count
Green/White Label, Losartan potassium tablets, 25 mg, 1000 count
Brown/White Label, Losartan potassium tablets, 50 mg, 30 count
Brown/White Label, Losartan potassium tablets, 50 mg, 90 count
Brown/White Label, Losartan potassium tablets, 50 mg, 1000 count
Purple/White Label, Losartan potassium tablets, 100 mg, 90 count
Purple/White Label, Losartan potassium tablets, 100mg, 1000 count
Image, losartan potassium and hydrochlorothiazide tablet 50 mg/12.5 mg
Image, losartan potassium and hydrochlorothiazide tablet 100 mg/12.5 mg
Image, losartan potassium and hydrochlorothiazide tablet 100 mg/25 mg
Green/White Label, losartan potassium and hydrochlorothiazide tablets 50 mg/12.5 mg, 30 count
Green/White Label, losartan potassium and hydrochlorothiazide tablets 50 mg/12.5 mg, 90 count

X

Green/White Label, losartan potassium and hydrochlorothiazide tablets 50 mg/12.5 mg, 1000 count
Brown/White Label, losartan potassium and hydrochlorothiazide tablets 100 mg/12.5 mg, 30 count
Brown/White Label, losartan potassium and hydrochlorothiazide tablets 100 mg/12.5 mg, 90 count
Brown/White Label, losartan potassium and hydrochlorothiazide tablets 100 mg/12.5 mg, 1000 count
Purple/White Label, losartan potassium and hydrochlorothiazide tablets 100 mg/25 mg, 30 count
Purple/White Label, losartan potassium and hydrochlorothiazide tablets 100 mg/25 mg, 90 count
Purple/White Label, losartan potassium and hydrochlorothiazide tablets 100 mg/25 mg, 1000 count

Partners

Recent Posts

Categories

Archives

RSS The Fifth Column News

%d bloggers like this: