Macleods Pharmaceuticals Limited Issues Voluntary Nationwide Recall Losartan Potassium Hydrochlorothiazide Combination Tablets

PUBLISHED: Feb 26, 2019
Relevant to: All Healthcare Organizations

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.

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.

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

Recalled Product Details:

Product Description: Losartan Potassium/ Hydrochlorothiazide combination tablets 100mg/25mg, 90 count bottles

Manufacturer: Macleods Pharmaceuticals Limited

NDC: 33342-0052-10

Lot/Batch: BLM715A

Expiration Date: Jul -2019

See the recall notice for a photo of the Label.

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).

Adverse reactions or quality problems associated with the use of this product may be reported to FDA's MedWatch Adverse Event Reporting program.

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