Drug Safety Alerts

Irbesartan Tablets Consumer-Level Recall

10/29/18

On October 29, 2018, ScieGen Pharmaceuticals, Inc. issued a consumer-level recall of Irbesartan tablets. This recall was issued due to the detection of trace amounts of an unexpected impurity, N-nitrosodiethylamine (NDEA), found in an active pharmaceutical ingredient (API) manufactured by Aurobindo Pharmaceuticals Limited. Irbesartan tablets, USP 75 mg, 150 mg, and 300 mg were manufactured by ScieGen Pharmaceuticals Inc and are labeled as Westminster Pharmaceuticals and Golden State Medical Supply, Inc.

A complete list of the affected products is provided at the end of this document. The products labeled as Golden State Medical Supply, Inc. are not carried by the CVS Caremark Mail Service Pharmacies.

A complete list of the affected products is provided here:

Please note: The United States Food and Drug Administration (FDA) recommends that patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication. Patients who are on Irbesartan should continue taking their medication, as the risk of harm to a patient’s health may be higher if the treatment is stopped immediately without any alternative treatment. Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using Irbesartan.

To date, ScieGen Pharmaceuticals, Inc. has not received any reports of adverse events related to this recall. At this time, CVS Caremark is not aware of any other manufacturers of Irbesartan that are being recalled.

CVS Caremark Response: Because of this action, CVS Caremark is in the process of contacting patients and prescribers to advise them of this recall. We are encouraging patients who are taking Irbesartan tablets to contact their prescriber.

For more information about the Westminster product recall, health care providers may contact Westminster Pharmaceuticals at 1‑888‑354‑9939, 9:00 am to 5:00 pm (ET). For more information about the Golden State product recall, health care providers may contact Golden State Medical Supply at 1-800- 284-8633 ext. 215, 7:30 am to 4:00 pm (PT). You may also contact the United States Food and Drug Administration (FDA) at 1‑888‑INFO-FDA (1‑888-463-6332) or visit https://www.fda.gov.