06/26/2019
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By Erin Smith

A recall for a popular blood pressure and heart failure medication has been expanded to include more medication that contain Losartan as an ingredient.  The medications are being  recalled due to impurities found in the Losartan that are a potential carcinogen.

The US Food and Drug Administration said the impurity is N-Nitroso-N-methyl-4-aminobutyric acid or NMBA. The company, Torrent Pharmaceuticals Limited, has voluntarily issued a recall of 87 lots of Losartan tablets made by the Hetero Labs Limited in Indiana.

According to a release regarding the recall, Losaratan is used to treat a variety of medical conditions including hypertension (high blood pressure), certain types of heart disease, and nephropathy is Type 2 diabetic patients.

Products being recalled include:

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

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

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.

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