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Torrent Pharmaceuticals expands recall of Losartan tablets

The products contain trace amounts of an unexpected impurity

Torrent Pharmaceuticals Limited is expanding its earlier recall of Losartan potassium tablets USP to include six lots of Losartan potassium and hydrochlorothiazide tablets, USP.

Photo
Photo source: FDA

Trace amounts of an unexpected impurity, N-nitrosodiethylamine (NDEA), which has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification.

There have been no reports of adverse events.

The following products, used to treat hypertension, hypertensive patients with Left Ventricular Hypertrophy and for the treatment of nephropathy in Type 2 diabetic patients, are being recalled:

NDCManufac.

Descrip.

Lot/BatchExpiration Date
115-30

Pharmaceu-

ticals LTD

LOSARTAN

POTASSIUM

TAB, USP

100mg,30count

bottles

BO31

C016

04/2019
13668-
115-90

Torrent 
Pharmace-

uticals LTD

LOSARTAN

POTASSIUM TAB

USP

100mg

90count

bottles

BO31

C016

04/2019
13668-
115-10

Torrent 
Pharmace-

uticals LTD

LOSARTAN

POTASSIUM TAB

USP 
100mg

1000-count

bottles

4DK3

C005

04/2019
13668-
115-10

Torrent 
Pharmace-

uticals LTD

LOSARTAN

POTASSIUM TAB

USP 
100mg

1000-count

bottles

4DK3

C004

04/2019
13668-
115-10

Torrent 
Pharmace-

uticals LTD

LOSARTAN

POTASSIUM TAB

USP 
100mg

1000-count

bottles

4DU3

C040

10/2019
13668-
115-10

Torrent 
Pharmace-

uticals LTD

LOSARTAN

POTASSIUM TAB

USP 
100mg

1000-count

bottles

4DU3

E049

05/2021
13668-
115-10

Torrent 
Pharmace-

uticals LTD

LOSARTAN

POTASSIUM TAB

USP 
100mg

1000-count

bottles

4DU3

E050

05/2021
13668-
409-30

Torrent 
Pharmace-

uticals LTD

LOSARTAN

POTASSIUM TAB

USP 50mg

30count

bottles

4L67

C035

10/2019
13668-
409-90

 

Torrent 
Pharmace-

uticals LTD

LOSARTAN

POTASSIUM TAB

USP 50mg

90count

bottles

4L67

C035

10/2019
13668-
409-90

Torrent 
Pharmace-

uticals LTD

LOSARTAN

POTASSIUM TAB

USP 50mg

90count

bottles

4L67

C036

10/2019
13668-
409-10

Torrent 
Pharmace-

uticals LTD

LOSARTAN

POTASSIUM TAB

USP 
50mg

1000-count

bottles

4O50

C005

11/2019
13668-
113-90

Torrent 
Pharmace-

uticals LTD

LOSARTAN

POTASSIUM TAB

USP 25mg

90count

bottles

4O49

C013

09/2019
13668-
116-90

Torrent 
Pharmace-

uticals LTD

LOSARTAN

POTASSIUM and

 
HYDROCHOLORO-

THIAZIDE TABLETS

USP
50mg/12.5 mg

90 count bottles.

BP02

C008

03/2019
13668-
116-10

Torrent 
Pharmace-

uticals LTD

LOSARTAN

POTASSIUM

and 
HYDROCHO LORO THIAZIDE TABLETS

USP
50mg/12.5 mg

1000 count bottles.

BEF7

D006

03/2020
13668-
117-90

Torrent 
Pharmace-

uticals LTD

LOSARTAN

POTASSIUM and 
HYDROCHOLORO-

THIAZIDE TABLETS

USP
100 mg/12.5 mg

90 count bottles.

BX35

C020

05/2019
13668-
117-90

Torrent 
Pharmace-

uticals LTD

LOSARTAN

POTASSIUM

and 
HYDROCHOLORO-

THIAZIDE TABLETS

USP
100 mg/12.5 mg

90 count bottles.

BX35

C049

08/2019
13668-
117-10

Torrent 
Pharmace-

uticals LTD

LOSARTAN

POTASSIUM and 
HYDROCHOLOR-

OTHIAZIDE TABLETS

USP
100 mg/12.5 mg

1000 count bottles.

BX35

C022

05/2019
13668-
117-10

Torrent 
Pharmace-

uticals LTD

LOSARTAN

POTASSIUM and 


HYDROCHOLORO-

THIAZIDE TABLETS

USP
100 mg/12.5 mg

1000 count bottles.

BX35

C023

05/2019

The recalled products were distributed nationwide to Torrent’s wholesale distributor, repackager and retail customers.

What to do

Patients who are on Losartan 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.

Torrent Pharmaceuticals is notifying customers by phone and in writing, arranging for return of all recalled products to Qualanex. Instructions for returning recalled products are given in the recall letter.

Consumers with medical questions or reporting an adverse event may contact Torrent at (800) 912-9561 8:00 am – 5:00 pm (ET), or by email at Medinfo.Torrent@apcerls.com

Questions regarding the return of the recalled product may be be directed to Qualanex at (888) 280-2040 from 8 am - 9:00 pm (ET).

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