Macleods Pharmaceutical Limited Issues Voluntary Nationwide Consumer Level


URGENT!!!    DRUG RECALL!!!     URGENT!!!

NDC Description Lot # Expiration Date
33342004510 Losartan Potassium Tablets USP 50mg 90ct BLl711A 11/1/2019
33342004544 Losartan Potassium Tablets USP 50mg 1000ct BLl710A 11/1/2019
33342005010 Losartan Potassium and Hydrochlorothiazide Tablets 50 mg/ 12.5 mg BLK719A 9/1/2019
  Losartan Potassium and Hydrochlorothiazide Tablets 50 mg/ 12.5 mg BLK720A 9/1/2019
  Losartan Potassium and Hydrochlorothiazide Tablets 50 mg/ 12.5 mg BLK721A 9/1/2019
  Losartan Potassium and Hydrochlorothiazide Tablets 50 mg/ 12.5 mg BLK722A 9/1/2019
  Losartan Potassium and Hydrochlorothiazide Tablets 50 mg/ 12.5 mg BLK723A 9/1/2019
  Losartan Potassium and Hydrochlorothiazide Tablets 50 mg/ 12.5 mg BLK724A 9/1/2019
  Losartan Potassium and Hydrochlorothiazide Tablets 50 mg/ 12.5 mg BLK725A 10/1/2019
  Losartan Potassium and Hydrochlorothiazide Tablets 50 mg/ 12.5 mg BLK726A 10/1/2019
  Losartan Potassium and Hydrochlorothiazide Tablets 50 mg/ 12.5 mg BLK804A 1/1/2020
  Losartan Potassium and Hydrochlorothiazide Tablets 50 mg/ 12.5 mg BLK806A 1/1/2020
  Losartan Potassium and Hydrochlorothiazide Tablets 50 mg/ 12.5 mg BLK825A 10/1/2021
  Losartan Potassium and Hydrochlorothiazide Tablets 50 mg/ 12.5 mg BLK826A 10/1/2021
33342005110 Losartan Potassium and Hydrochlorothiazide Tablets 100 mg/ 12.5 mg BLL801A 12/1/2019
  Losartan Potassium and Hydrochlorothiazide Tablets 100 mg/ 12.5 mg BLL802A 12/1/2019
  Losartan Potassium and Hydrochlorothiazide Tablets 100 mg/ 12.5 mg BLL803A 12/1/2019
33342005210 Losartan Potassium and Hydrochlorothiazide Tablets 100 mg/ 25 mg BLM716A 7/1/2019
  Losartan Potassium and Hydrochlorothiazide Tablets 100 mg/ 25 mg BLM717A 7/1/2019
  Losartan Potassium and Hydrochlorothiazide Tablets 100 mg/ 25 mg BLM719A 8/1/2019
  Losartan Potassium and Hydrochlorothiazide Tablets 100 mg/ 25 mg BLM720A 8/1/2019
  Losartan Potassium and Hydrochlorothiazide Tablets 100 mg/ 25 mg BLM721A 9/1/2019
  Losartan Potassium and Hydrochlorothiazide Tablets 100 mg/ 25 mg BLM722A 9/1/2019
  Losartan Potassium and Hydrochlorothiazide Tablets 100 mg/ 25 mg BLM723A 10/1/2019
  Losartan Potassium and Hydrochlorothiazide Tablets 100 mg/ 25 mg BLM724A 10/1/2019
  Losartan Potassium and Hydrochlorothiazide Tablets 100 mg/ 25 mg BLM725A 10/1/2019
  Losartan Potassium and Hydrochlorothiazide Tablets 100 mg/ 25 mg BLM726A 11/1/2019
  Losartan Potassium and Hydrochlorothiazide Tablets 100 mg I 25 mg BLM802A 12/1/2019
  Losartan Potassium and Hydrochlorothiazide Tablets 100 mg/ 25 mg BLM803A 12/1/2019
  Losartan Potassium and Hydrochlorothiazide Tablets 100 mg/ 25 mg BLM825A 9/1/2021
  Losartan Potassium and Hydrochlorothiazide Tablets 100 mg/ 25 mg BLM826A 9/1/2021
  Losartan Potassium and Hydrochlorothiazide Tablets 100 mg/ 25 mg BLM827A 9/1/2021


Macleods Pharmaceuticals Limited has initiated a voluntary recall in the United States, to the patient level, of 32 lots of Losartan Potassium USP Tablets (2 lots of 50mg strength) and Losartan Potassium/Hydrochlorothiazide combination Tablets (12 lots  of  50mg/12.5mg strength, 3 lots of 100mg/12.5mg strength and 15 100mg/25mg strength) to the patient level due to the detection of trace amounts of an unexpected impurity, N-Nitroso-N-methyl-4-aminobutyric acid (NMBA). The impurity was found in 32 lots of active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited that is above the US Food & Drug Administration's interim acceptable exposure limit of 9.82 ppm. Based on the available information, the risk of developing cancer in a few patients following long-term use of the product cannot be ruled out.


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

Contact:

Macleods Pharmaceuticals: Macleods Pharmaceuticals 855-926-3384