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Macleods recalls Losartan Potassium and Losartan Potassium/Hydrochlorothiazide tablets

The products contain trace amounts of a potential human carcinogen

Photo
Photo source: FDA
Macleods Pharmaceuticals Limited is recalling Losartan Potassium tablets and Losartan Potassium/Hydrochlorothiazide combination tablets used to treat hypertension and hypertensive patients with Left Ventricular Hypertrophy.

The products contain trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA), a potential human carcinogen.

The firm has not received any reports of adverse events to date.

The following products, packaged in bottles, are being recalled:

Losartan Potassium-

Tablets 50 mg

NDCManuf.Product DescriptionLotExpiration Date

33342-

045-10

Macleods Pharmac-

euticals

Limited

Losartan

Potassium.

Tablets USP

50mg 90ct

BLl

711A

Nov-19

33342-

045-44

Macleods Pharmac-

euticals

Limited

Losartan

Potassium

Tablets USP

50mg 1000ct

BLl

710A

Nov-19

Losartan Potassium and Hydro-

chlorothiazide Tablets 50 mg/ 12.5 mg

NDCManuf.Product DescriptionLotExpiration Date

33342-

050-10

Macleods Pharmac-

euticals

Limited

Losartan

Potassium and Hydrochlor-

othiazide

Tablets 50 mg/

12.5 mg

BLK7

19A

Sep-19

33342-

050-10

Macleods Pharmac-

euticals

Limited

Losartan

Potassium and Hydrochlor-

othiazide

Tablets 50

mg/ 12.5 mg

BLK7

20A

Sep-19

33342-

050-10

Macleods Pharmac-

euticals

Limited

Losartan

Potassium and Hydrochlor-

othiazide

Tablets 50

mg/ 12.5 mg

BLK7

21A

Sep-19

33342-

050-10

Macleods Pharmac-

euticals

Limited

Losartan

Potassium

and Hydrochlor-othiazide Tablets 50 mg/ 12.5 mg

BLK7

22A

Sep-19

33342-

050-10

Macleods Pharmac-

euticals

Limited

Losartan

Potassium and Hydrochlor-

othiazide

Tablets 50

mg/ 12.5 mg

BLK7

23A

Sep-19

33342-

050-10

Macleods Pharmac-

euticals

Limited

Losartan

Potassium and Hydrochlor-

othiazide 

Tablets 50 

mg/ 12.5 mg

BLK7

24A

Sep-19

33342-

050-10

Macleods Pharmac-

euticals

Limited

Losartan

Potassium and Hydrochlor-

othiazide 

Tablets 50 

mg/ 12.5 mg

BLK7

25A

Oct-19

33342-

050-10

Macleods Pharmac-

euticals

Limited

Losartan

Potassium and Hydrochlor-

othiazide 

Tablets 50 

mg/ 12.5 mg

BLK72

6A

Oct-19

33342-

050-10

Macleods Pharmac-

euticals

Limited

Losartan

Potassium and Hydrochlor-

othiazide 

Tablets 50 

mg/ 12.5 mg

BLK8

04A

Jan-20

33342-

050-10

Macleods Pharmac-

euticals

Limited

Losartan

Potassium and Hydrochlor-

othiazide 

Tablets 50 

mg/ 12.5 mg

BLK8

06A

Jan-20

33342-

050-10

Macleods Pharmac-

euticals

Limited

Losartan

Potassium and Hydrochlor-

othiazide 

Tablets 50 

mg/ 12.5 mg

BLK8

25A

Oct-21

33342-

050-10

Macleods Pharmac-

euticals

Limited

Losartan

Potassium and Hydrochlor-

othiazide 

Tablets 50 

mg/ 12.5 mg

BLK8

26A

Oct-21

Losartan Potassium and Hydrochlo.

Tablets 100 mg/ 12.5 mg

NDCManuf.Product DescriptionLotExpiration Date

33342-

051-10

Macleods Pharmac-

euticals

Limited

Losartan 

Potassium 

and Hydrochlor-

othiazide 

Tablets 100

mg/ 25 mg

BLL

801A

Dec-19

33342-

051-10

Macleods Pharmac-

euticals

Limited

Losartan 

Potassium 

and Hydrochlor-

othiazide 

Tablets 100

mg/ 25 mg

BLL

802A

Dec-19

33342-

051-10

Macleods Pharmac-

euticals

Limited

Losartan 

Potassium 

and Hydrochlor-

othiazide 

Tablets 100

mg/ 25 mg

BLL

803A

Dec-19

Losartan Potassium and Hydrochlor.

Tablets 100 mg/ 25 mg

NDCManuf.Product DescriptionLotExpiration Date

33342-

052-10

Macleods Pharmac-

euticals

Limited

Losartan

Potassium

and Hydrochlor-

othiazide

Tablets 100

mg/ 25 mg

BLM

716A

Jul-19

33342-

052-10

Macleods Pharmac-

euticals

Limited

Losartan 

Potassium 

and Hydrochlor-

othiazide 

Tablets 100

mg/ 25 mg

BLM

717A

Jul-19

33342-

052-10

Macleods Pharmac-

euticals

Limited

Losartan 

Potassium 

and Hydrochlor-

othiazide 

Tablets 100

mg/ 25 mg

BLM

719A

Aug-19

33342-

052-10

Macleods Pharmac-

euticals

Limited

Losartan 

Potassium 

and Hydrochlor-

othiazide 

Tablets 100

mg/ 25 mg

BLM

720A

Aug-19

33342-

052-10

Macleods Pharmac-

euticals

Limited

Losartan 

Potassium 

and Hydrochlor-

othiazide 

Tablets 100

mg/ 25 mg

BLM

721A

Sep-19

33342-

052-10

Macleods Pharmac-

euticals

Limited

Losartan 

Potassium 

and Hydrochlor-

othiazide 

Tablets 100

mg/ 25 mg

BLM

722A

Sep-19

33342-

052-10

Macleods Pharmac-

euticals

Limited

Losartan 

Potassium 

and Hydrochlor-

othiazide 

Tablets 100

mg/ 25 mg

BLM

723A

Oct-19

33342-

052-10

Macleods Pharmac-

euticals

Limited

Losartan 

Potassium 

and Hydrochlor-

othiazide 

Tablets 100

mg/ 25 mg

BLM

724A

Oct-19

33342-

052-10

Macleods Pharmac-

euticals

Limited

Losartan 

Potassium 

and Hydrochlor-

othiazide 

Tablets 100

mg/ 25 mg

BLM

725A

Oct-19

33342-

052-10

Macleods Pharmac-

euticals

Limited

Losartan 

Potassium 

and Hydrochlor-

othiazide 

Tablets 100

mg/ 25 mg

BLM

726A

Nov-19

33342-

052-10

Macleods Pharmac-

euticals

Limited

Losartan 

Potassium 

and Hydrochlor-

othiazide 

Tablets 100

mg/ 25 mg

BLM

802A

Dec-19

33342-

052-10

Macleods Pharmac-

euticals

Limited

Losartan 

Potassium 

and Hydrochlor-

othiazide 

Tablets 100

mg/ 25 mg

BLM

803A

Dec-19

33342-

052-10

 

Macleods Pharmac-

euticals

Limited

Losartan 

Potassium 

and Hydrochlor-

othiazide 

Tablets 100

mg/ 25 mg

BLM

825A

Sep-21

33342-

052-10

Macleods Pharmac-

euticals

Limited

Losartan 

Potassium 

and Hydrochlor-

othiazide 

Tablets 100

mg/ 25 mg

BLM

826A

Sep-21

33342-

052-10

Macleods Pharmac-

euticals

Limited

Losartan 

Potassium 

and Hydrochlor-

othiazide 

Tablets 100

mg/ 25 mg

BLM

827A

Sep-21
 

The products can be identified by checking the product name, manufacturer details and batch or lot number on the bottle.

What to do

Patients who are on the recalled medications should continue taking them and contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment, as the risk of harm to the patient's health may be higher if the treatment is stopped immediately without any alternative treatment.

Patients with medical questions regarding this recall or to report an adverse event may contact Macleods at (855) 926-3384 (8:00 am – 5:00 pm (EST).

Macleods is arranging for return of all recalled products to Qualanex. Instructions for returning recalled products are given in the recall letter.

Consumers with general questions regarding the return of the recalled product may contact Qualanex (888) 280-2046, 7:00 am to 4:00 pm (CST) Monday – Friday or by email at recall@qualanex .com.

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