Losartan Recalled Due to Nitroso-N-methyl-4-aminobutyric Acid

An Additional Thirty-Two Lots of the Blood Pressure Medication Losartan Have Been Recalled

Losartan recalled

UNITED STATES – According to an online news article published by www.miamiherald.com, an additional thirty-two lots of the heart and blood pressure medication Losartan has been recalled for evidence of contamination with a known carcinogen.

Losartan, Valsartan, and other similar heart and blood pressure medications have been scrutinized over the past year because of carcinogenic impurities found in the medication.  With each recall by various pharmaceutical companies, a new carcinogenic substance is identified.  Initial recalls of Losartan and Valsartan were found to be contaminated with NDEA.

The thirty-two lots of recalled Losartan, manufactured by MacLeods Pharmaceuticals Limited, were found to be contaminated with NMBA (Nitroso-N-methyl-4-aminobutyric acid).  The amount of NMBA found in the specific lots of Losartan was well above the United States Food and Drug Administration’s (FDA) limit of 9.82 parts per million.

Specific Losartan Lots Subject to Recent Recall

The following lots of Losartan, manufactured by MacLeods Pharmaceuticals, are currently subject to recall:

• Losartan Potassium/Hydrochlorothiazide 100mg/25mg, lot Nos. BLM716A, 717A, 719A through 726A, 802A, 803A, 825A through 827A
• Losartan Potassium/Hydrochlorothiazide 50mg/12.5mg, lot Nos. BLK719A through 726A, 804A, 806A, 825A, 826A
• Losartan Potassium/Hydrochlorothiazide 100mg/12.5mg, lot Nos. BLL801A through 803A
• Losartan Potassium USP tablets 50mg, 90-count, lot No. BLI711A; 1,000-count, lot No. BLI710A

Each of these lots was distributed and sold nationwide to wholesale distributors and retail stores.  While it is unclear whether a person taking Losartan or Valsartan is at a greater chance of developing cancer, the risk is significant enough for MacLeods Pharmaceuticals to issue a recall of the affected lots of Losartan.