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Home > Recalled Products > Drugs > Elevated Impurity > Macleods Losartan Potassium/Hydrochlorothiazide Combination Tablets 100mg/25mg

Recall: Macleods Losartan Potassium/Hydrochlorothiazide Combination Tablets 100mg/25mg

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On 2019-02-22, the FDA announced that Macleods Pharmaceuticals Limited is conducting a recall on Losartan Potassium/Hydrochlorothiazide Combination Tablets 100mg/25mg due to a possible ndea (n-nitrosodiethylamine) . The recalled products were sold under the brand name(s) Macleods during an unspecified time period throughout the regions shown in the map below.

In recent months, there have been 5 drugs recalls due to potential elevated impurity, including irbesartan and irbesartan hctz tablets, losartan potassium tablets usp and more. Additionally, there have been 14 drug and medical device recalls due to other health hazards as well as 78 food recalls.

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Macleods Losartan Potassium/ Hydrochlorothiazide Combination Tablets, Label
Note: Images may not be available for every version. Please review the detailed description below.

Company Contact Information:

Name: Macleods Pharmaceuticals Limited
Phone: 888-280-2042

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Detailed Recall Information



Regions Where Sold: Because the region was not specified, it is assumed that this product was available nationwide.

Product Description: Losartan Potassium/Hydrochlorothiazide Combination Tablets 100mg/25mg

Brand Name(s): Macleods

Reason for Recall: NDEA (N-Nitrosodiethylamine) Impurity

Official Recall Date: 2019-02-22


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Additional information provided by the FDA.gov:

Macleods Pharmaceuticals Limited Issues Voluntary Nationwide Consumer Level Recall of One Lot (BLM 715A) of Losartan Potassium/Hydrochlorothiazide Combination Tablets 100mg/25mg Due to detection of NDEA (N-Nitrosodiethylamine) Impurity

For Immediate Release
February 22, 2019

Contact
Consumers

Qualanex
recall@qualanex.com
888-280-2042

Announcement

Macleods Pharmaceuticals Limited is voluntarily recalling one lot of Losartan Potassium/Hydrochlorothiazide combination tablets 100mg/25mg to the consumer level due to the detection of trace amounts of an unexpected impurity (NDEA) found in finished product manufactured with active pharmaceutical ingredient made by Hetero Labs Limited.

Risk Statement: The impurity detected is N-nitrosodiethylamine (NDEA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification. Macleods is recalling one lot of Losartan Potassium/Hydrochlorothiazide combination tablets 100mg/25mg that contains NDEA above the interim acceptable daily intake levels released by the FDA.

To date, Macleods Pharmaceuticals Limited has not received any reports of adverse events related to this recall.

Losartan Potassium/Hydrochlorothiazide combination tablets are indicated to treat hypertension and hypertensive patients with Left Ventricular Hypertrophy. Patients who are on Losartan Potassium/Hydrochlorothiazide combination 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.

The product subject to recall is listed below and packaged in bottles. The product can be identified by checking the product name, manufacturer details and batch or lot number on the bottle containing these products.

NDC Manufacturer Product Description Lot/Batch Expiration Date
33342-0052-10 Macleods Pharmaceuticals Limited Losartan Potassium/ Hydrochlorothiazide combination tablets 100mg/25mg, 90 count bottles BLM715A Jul -2019

The representation of the Label is as provided below.

Losartan Potassium/Hydrochlorothiazide combination tablets 100mg/25mg were distributed nationwide to Macleods wholesale distributor and retail customers. Macleods Pharmaceuticals Limited is notifying its distributors and customers by phone and/or in writing to immediately discontinue distribution of the specific lot being recalled and to notify their sub-accounts. Macleods is arranging for return of all recalled products to Qualanex. Instructions for returning recalled products are given in the recall letter.

If you have any general questions regarding the return of this product please contact Qualanex via email at recall@qualanex.com or call 888-280-2042 (7:00 am to 4:00 pm CST Monday to Friday).

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.

Adverse reactions or quality problems associated with the use of this product may be reported to FDA's MedWatch Adverse Event Reporting program by phone, on line, either 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 or 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. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.


More information may be available at FDA.gov
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Sources may include Food & Drug Administration (FDA), United States Department of Agriculture (USDA), Health Canada and companies involved with this or a related recall.

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