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

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

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

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

Summary

Company Announcement Date:
April 18, 2019
FDA Publish Date:
May 03, 2019
Product Type:
Drugs
Generic Drugs
Reason for Announcement:
Company Name:
Torrent Pharmaceuticals Limited
Brand Name:
Brand Name(s)
Torrent Pharmaceuticals Limited
Product Description:
Product Description
Losartan potassium tablets, USP; Losartan potassium and Hydrochlorothiazide tablets, USP

Company Announcement

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 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 by checking 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

NDC Finished Product Strength and Package Count Batch Number Expiration Date
13668-113-90 Losartan Potassium Tablets, USP 25mg, 90 count 4DU1E005 1/31/2021
13668-113-90 Losartan Potassium Tablets, USP 25mg, 90 count 4DU1E006 1/31/2021
13668-113-90 Losartan Potassium Tablets, USP 25mg, 90 count 4DU1E008 1/31/2021
13668-113-10 Losartan Potassium Tablets, USP 25mg, 1000 count 4DU1E007 1/31/2021
13668-409-30 Losartan Potassium Tablets, USP 50mg, 30 count 4DU2D077 10/31/2020
13668-409-90 Losartan Potassium Tablets, USP 50mg, 90 count 4DU2D087 10/31/2020
13668-409-90 Losartan Potassium Tablets, USP 50mg, 90 count 4DU2E023 1/31/2021
13668-409-90 Losartan Potassium Tablets, USP 50mg, 90 count 4DU2E024 1/31/2021
13668-409-90 Losartan Potassium Tablets, USP 50mg, 90 count 4DU2E026 1/31/2021
13668-409-90 Losartan Potassium Tablets, USP 50mg, 90 count 4DU2E027 1/31/2021
13668-409-90 Losartan Potassium Tablets, USP 50mg, 90 count 4DU2E028 1/31/2021
13668-409-90 Losartan Potassium Tablets, USP 50mg, 90 count 4DU2E029 1/31/2021
13668-409-90 Losartan Potassium Tablets, USP 50mg, 90 count 4DU2E020 1/31/2021
13668-409-90 Losartan Potassium Tablets, USP 50mg, 90 count 4O50E007 8/31/2021
13668-409-90 Losartan Potassium Tablets, USP 50mg, 90 count 4O50E008 8/31/2021
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2D067 9/30/2020
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2D069 9/30/2020
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2D063 9/30/2020
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2D064 9/30/2020
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2D065 9/30/2020
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2D066 9/30/2020
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2D084 10/31/2020
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2D085 10/31/2020
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2D083 10/31/2020
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2D082 10/31/2020
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2D072 10/31/2020
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2D077 10/31/2020
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2D078 10/31/2020
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2D079 10/31/2020
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2D081 10/31/2020
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2D080 10/31/2020
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2D070 10/31/2020
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2D073 10/31/2020
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2D074 10/31/2020
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2D075 10/31/2020
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2D086 10/31/2020
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2D088 10/31/2020
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2D089 10/31/2020
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2E019 1/31/2021
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2E021 1/31/2021
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2E022 1/31/2021
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2E025 1/31/2021
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2E032 2/28/2021
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2E033 2/28/2021
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2E034 2/28/2021
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2E035 2/28/2021
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2E036 2/28/2021
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2E037 2/28/2021
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2E038 2/28/2021
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2E039 2/28/2021
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2E041 2/28/2021
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2E103 6/30/2021
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2E101 6/30/2021
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2E102 6/30/2021
13668-115-90 Losartan Potassium Tablets, USP 100mg, 90 count 4DU3E014 1/31/2021
13668-115-90 Losartan Potassium Tablets, USP 100mg, 90 count 4DU3E015 1/31/2021
13668-115-90 Losartan Potassium Tablets, USP 100mg, 90 count 4DU3E065 7/31/2021
13668-115-10 Losartan Potassium Tablets, USP 100mg, 1000 count 4DU3D018 11/30/2020
13668-115-10 Losartan Potassium Tablets, USP 100mg, 1000 count 4DU3E062 6/30/2021
13668-115-10 Losartan Potassium Tablets, USP 100mg, 1000 count 4DU3E063 6/30/2021
13668-116-30 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 30 count BEF7D017 6/30/2020
13668-116-90 Losartan Potassium /Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 count BEF7D010 4/30/2020
13668-116-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 count BEF7D011 4/30/2020
13668-116-90 Losartan Potassium /Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 count BEF7D018 6/30/2020
13668-116-90 Losartan Potassium / Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 count BEF7D009 4/30/2020
13668-116-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 count 4P02E002 1/31/2021
13668-116-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 count 4P02E003 1/31/2021
13668-116-90 Losartan Potassium / Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 count 4P02E004 1/31/2021
13668-116-10 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 1000 count BEF7D008 4/30/2020
13668-116-10 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 1000 count BEF7D022 8/31/2020
13668-116-10 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 1000 count BEF7D012 4/30/2020
13668-116-10 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 1000 count BEF7D013 4/30/2020
13668-116-10 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 1000 count BEF7D049 11/30/2020
13668-116-10 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 1000 count 4P02E005 1/31/2021
13668-116-10 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 1000 count 4P02E006 1/31/2021
13668-117-30 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 30 count BEF8D058 11/30/2020
13668-117-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 count BEF8D023 4/30/2020
13668-117-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 count BEF8D024 4/30/2020
13668-117-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 count BEF8D025 4/30/2020
13668-117-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 count BEF8D009 3/31/2020
13668-117-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 count BEF8D010 3/31/2020
13668-117-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 count BEF8D011 3/31/2020
13668-117-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 count BEF8D012 3/31/2020
13668-117-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 count BEF8D013 3/31/2020
13668-117-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 count BEF8D054 10/31/2020
13668-117-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 count BEF8D055 10/31/2020
13668-117-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 count BEF8D056 10/31/2020
13668-117-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 count BEF8D057 11/30/2020
13668-117-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 count BEF8D007 3/31/2020
13668-117-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 count BEF8D008 3/31/2020
13668-117-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 count BEF8D020 4/30/2020
13668-117-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 count BEF8D021 4/30/2020
13668-117-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 count BEF8D022 4/30/2020
13668-118-30 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 30 count BEF6D038 4/30/2020
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count BEF6D030 4/30/2020
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count BEF6D031 4/30/2020
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count BEF6D047 7/31/2020
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90count BEF6D048 7/31/2020
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count BEF6D049 7/31/2020
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count BEF6D050 7/31/2020
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count BEF6D051 7/31/2020
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count BEF6D082 10/31/2020
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count BEF6D083 10/31/2020
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count BEF6D084 10/31/2020
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count BEF6D085 10/31/2020
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count BEF6D086 10/31/2020
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count BEF6D087 10/31/2020
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count 4P04E003 1/31/2021
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count 4P04E004 1/31/2021
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count 4P04E005 1/31/2021
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count 4P04E006 1/31/2021
13668-118-10 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 1000 count 4P04E007 1/31/2021
13668-118-10 Losartan Potassium/Hydrochlorothiazide Tablets, USP 100mg/25mg, 1000 count 4P04E008 1/31/2021
13668-118-10 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 1000 count 4P04E009 1/31/2021
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count BEF6D051 7/31/2020
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count BEF6D082 10/31/2020
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count BEF6D083 10/31/2020
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count BEF6D084 10/31/2020
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count BEF6D085 10/31/2020
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count BEF6D086 10/31/2020
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count BEF6D087 10/31/2020
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count 4P04E003 1/31/2021
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count 4P04E004 1/31/2021
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count 4P04E005 1/31/2021
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count 4P04E006 1/31/2021
13668-118-10 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 1000 count 4P04E007 1/31/2021
13668-118-10 Losartan Potassium/Hydrochlorothiazide Tablets, USP 100mg/25mg, 1000 count 4P04E008 1/31/2021
13668-118-10 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 1000 count 4P04E009 1/31/2021
13668-113-90 Losartan Potassium Tablets, USP 25mg, 90 count BDK1C003 7/31/2019
13668-113-10 Losartan Potassium Tablets, USP 25mg, 1000 count BDK1C002 7/31/2019
13668-113-10 Losartan Potassium Tablets, USP 25mg, 1000 count 4DU1D004 12/31/2019
13668-113-10 Losartan Potassium Tablets, USP 25mg, 1000 count 4DU1D005 12/31/2019
13668-113-10 Losartan Potassium Tablets, USP 25mg, 1000 count 4DU1D006 12/31/2019
13668-409-90 Losartan Potassium Tablets, USP 50mg, 90 count 4DU2D005 12/31/2019
13668-409-90 Losartan Potassium Tablets, USP 50mg, 90 count 4DU2D006 12/31/2019
13668-409-90 Losartan Potassium Tablets, USP 50mg, 90 count 4DU2D026 3/31/2020
13668-409-90 Losartan Potassium Tablets, USP 50mg, 90 count 4DU2D027 3/31/2020
13668-409-90 Losartan Potassium Tablets, USP 50mg, 90 count 4DU2D029 3/31/2020
13668-409-90 Losartan Potassium Tablets, USP 50mg,90 count 4DU2E007 12/31/2020
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2D040 8/31/2020
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2D041 8/31/2020
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2D042 8/31/2020
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2D017 2/29/2020
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2D025 3/31/2020
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2D028 3/31/2020
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2D045 8/31/2020
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2D046 8/31/2020
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2D047 8/31/2020
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2D048 8/31/2020
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2E042 2/28/2021
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count 4DU2E044 2/28/2021
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count BDK2E001 12/31/2020
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count BDK2E012 8/31/2021
13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count BDK2E013 8/31/2021
13668-115-90 Losartan Potassium Tablets, USP 100mg, 90 count 4DU3E016 1/31/2021
13668-115-10 Losartan Potassium Tablets, USP 100mg, 1000 count 4DU3E017 1/31/2021
13668-115-10 Losartan Potassium Tablets, USP 100mg, 1000 count 4DU3E019 2/28/2021
13668-115-10 Losartan Potassium Tablets, USP 100mg, 1000 count 4DU3C012 7/31/2019
13668-115-10 Losartan Potassium Tablets, USP 100mg, 1000 count 4DU3C015 8/31/2019
13668-115-10 Losartan Potassium Tablets, USP 100mg, 1000 count 4DU3C016 8/31/2019
13668-115-10 Losartan Potassium Tablets, USP 100mg, 1000 count 4DU3C017 8/31/2019
13668-115-10 Losartan Potassium Tablets, USP 100mg, 1000 count 4DU3C031 9/30/2019
13668-115-10 Losartan Potassium Tablets, USP 100mg, 1000 count 4DU3D007 1/31/2020
13668-115-10 Losartan Potassium Tablets, USP 100mg, 1000 count 4DU3D008 1/31/2020
13668-116-30 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 30 count BP02D005 12/31/2019
13668-116-30 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 30 count BP02C051 10/31/2019
13668-116-30 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 30 count BEF7D047 11/30/2020
13668-116-90 Losartan Potassium /Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 count BP02D006 12/31/2019
13668-116-90 Losartan Potassium /Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 count BP02D007 12/31/2019
13668-116-90 Losartan Potassium /Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 count BP02D012 1/31/2020
13668-116-90 Losartan Potassium /Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 count BEF7D003 3/31/2020
13668-116-90 Losartan Potassium /Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 count BP02C050 10/31/2019
13668-116-90 Losartan Potassium /Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 count BEF7D026 8/31/2020
13668-116-90 Losartan Potassium /Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 count BEF7D027 8/31/2020
13668-116-90 Losartan Potassium /Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 count BEF7D028 8/31/2020
13668-116-90 Losartan Potassium /Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 count BEF7D045 11/30/2020
13668-116-90 Losartan Potassium /Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 count BEF7D046 11/30/2020
13668-116-90 Losartan Potassium /Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 count BEF7E005 1/31/2021
13668-116-10 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 1000 count BEF7D005 3/31/2020
13668-116-10 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 1000 count BEF7D029 8/31/2020
13668-116-10 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 1000 count BEF7D030 8/31/2020
13668-116-10 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 1000 count BEF7D048 11/30/2020
13668-116-10 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 1000 count BEF7E001 12/31/2020
13668-116-10 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 1000 count BEF7E002 12/31/2020
13668-116-10 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 1000 count BEF7E003 12/31/2020
13668-116-10 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 1000 count BEF7E004 12/31/2020
13668-116-10 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 1000 count BP02C051 10/31/2019
13668-116-10 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 1000 count BP02C052 10/31/2019
13668-117-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 count BEF8D060 11/30/2020
13668-117-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 count BEF8D061 11/30/2020
13668-117-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 count BEF8D062 11/30/2020
13668-117-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 count BEF8D063 11/30/2020
13668-117-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 count BX35D024 1/31/2020
13668-117-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 90 count BEF8D064 11/30/2020
13668-117-10 Losartan Potassium /Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 1000 count BEF8D059 11/30/2020
13668-117-10 Losartan Potassium /Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 1000 count BEF8E004 1/31/2021
13668-117-10 Losartan Potassium /Hydrochlorothiazide Tablets, USP 100mg/12.5mg, 1000 count BEF8E005 1/31/2021
13668-118-30 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 30 count BEF6D054 8/31/2020
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count BEF6D100 11/30/2020
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count BEF6D101 11/30/2020
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count BEF6D102 11/30/2020
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count BEF6E001 12/31/2020
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count BEF6E002 12/31/2020
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count BEF6E003 12/31/2020
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count BEF6E004 12/31/2020
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count BEF6E008 12/31/2020
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count BEF6E009 12/31/2020
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count BEF6E010 12/31/2020
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count BEF6E011 12/31/2020
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count BEF6E012 12/31/2020
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count BP04D012 12/31/2019
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count BP04D013 12/31/2019
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count BP04C092 10/31/2019
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count BEF6D012 3/31/2020
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count BEF6D013 3/31/2020
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count BEF6D060 9/30/2020
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count BEF6D061 9/30/2020
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count BEF6D063 9/30/2020
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count BEF6D076 10/31/2020
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count BEF6D077 10/31/2020
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count BEF6D078 10/31/2020
13668-118-90 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count BEF6D079 10/31/2020
13668-118-10 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 1000 count BP04C094 10/31/2019
13668-118-10 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 1000 count BEF6D096 11/30/2020
13668-118-10 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 1000 count BEF6D097 11/30/2020
13668-118-10 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 1000 count BEF6D098 11/30/2020
13668-118-10 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 1000 count BEF6D099 11/30/2020
13668-118-10 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 1000 count BEF6E005 12/31/2020
13668-118-10 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 1000 count BEF6E006 12/31/2020
13668-118-10 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 1000 count BP04D016 2/29/2020
13668-118-10 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 1000 count BP04D017 2/29/2020
13668-118-10 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 1000 count BP04D018 2/29/2020

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 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 Online: www.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


Company Contact Information

Consumers:
Torrent Medical Information
1-800-912-9561
Medinfo.Torrent@apcerls.com

Product Photos