Drug Safety Alerts

Losartan potassium Products - Consumer-level Recall

02/28/2019

On February 28, 2019, the United States Food and Drug Administration (FDA) issued a notice regarding a consumer-level recall of losartan potassium 25 mg, 50 mg and 100 mg tablets. This recall was prompted 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, Unit – I (API manufacturer).

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

Losartan Potassium Tablets were distributed Nationwide to Wholesalers, Distributors, Retail Pharmacies, and Mail Order Pharmacies.

Consumers should contact their doctor for further guidance and potential change of treatment before they stop taking the product. Pharmacies and healthcare facilities that have the product being recalled should stop using and dispensing the product immediately

CVS Caremark Response: Because of this action, CVS Caremark Mail Service Pharmacy contacting patients and prescribers to advise them of this recall. We are encouraging patients who are taking losartan potassium 25 mg, 50 mg and 100 mg tablets to contact their prescriber.

For more information, please contact Camber’s Medical Line toll-free at 1‑866‑495‑1995 or visit www.camberpharma.com. You may also call the United States Food and Drug Administration FDA consumer inquiry line at 1‑888‑INFO-FDA (1‑888-463-6332) or visit www.fda.gov.