Drug Safety Alerts

Golden State Losartan Potassium Extended Patient Level Recall

06/11/2019

OnJune 11, 2019, the United States Food and Drug Administration (FDA) issued a notice regarding an extended patient-level recall of Losartan Potassium 50 mg and 100 mg tablets manufactured by Teva Pharmaceuticals and distributed by Golden State Medical Supply. This recall was prompted due to Teva Pharmaceuticals USA issuing a voluntary nationwide recall of various losartan tablets, USP, due to the detection of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, (API manufacturer).

A complete list of the affected products is provided here:

Please note: This recall contained additional products and lot numbers that were not part of the previous recall issued on Losartan Potassium 25 mg and 100 mg tablets manufactured by Teva Pharmaceuticals and distributed by Golden State Medical Supply on April 27, 2019.

NMBA is a potential human carcinogen. To date, Teva has not received any reports of adverse events related to this recall.

Losartan potassium tablets, USP is a prescription medication used to treat high blood pressure and congestive heart failure.

Patients who are on Losartan Potassium 50 mg and 100 mg tablets 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. Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication.

CVS Caremark Response:

Please note: The Losartan Potassium 50 mg and 100 mg tablets distributed by Golden State Medical Supply are not carried by the CVS Caremark Mail Service Pharmacies.

For more information about this recall, health care providers may contact Golden State Medical Supply at 1-800-284-8633, ext. 215 or visit https://www.tevausa.com.

You may also contact the FDA consumer inquiry line at 1‑888‑INFO-FDA (1‑888-463-6332) or visit https://www.fda.gov.