FDA Drug Information Update on Angiotensin II Receptor (ARB) Recalls by Macleods Pharmaceuticals

PUBLISHED: Jun 27, 2019
Relevant to: All Healthcare Organizations

The US Food and Drug Administration (FDA) is alerting patients and health care professionals to Macleods Pharmaceuticals’ voluntary recall of two lots of losartan potassium tablets (50mg strength) and 30 lots of losartan potassium/hydrochlorothiazide (HCTZ) combination tablets (12 lots of 50mg/12.5mg strength, three lots of 100mg/12.5mg strength, and 15 lots of 100mg/25mg strength). This recall is due to unacceptable amounts of N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) in the losartan active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited.

FDA is working with manufacturers to reduce and remove nitrosamines from angiotensin II receptor blockers (ARBs). The agency also updated the list of recalled angiotensin II receptor blockers (ARBs).

FDA reminds patients taking recalled ARBs to continue taking their current medicine until their pharmacist provides a replacement or their doctor prescribes a different medication that treats the same condition.

See the recall notice for additional information included product label photos.

Want to read the full alert and receive alert emails?

Browse Additional Alerts