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Medication Safety Alerts

Irbesartan Tablets Voluntary recall

October 29, 2018

On October 29, 2018, ScieGen Pharmaceuticals, Inc. issued a voluntary recall of Irbesartan tablets. This recall was issued because an unexpected impurity was found in these products that can cause health risks. Irbesartan tablets 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. The Golden State Medical Supply, Inc. products are not carried by the CVS Caremark Mail Service Pharmacies.

This may represent a potential health hazard or safety risk to plan members who may be using product affected by this recall.

A complete list of the affected products is provided here:

If you received your product in the manufacturer’s bottle, please check the lot number. The lot number is on the lower right-hand side of the manufacturer’s bottle by the bar code. If your product is not from one of the affected lot numbers, it is not affected by this recall. If you received your product in a pharmacy bottle, products can be best identified as being white, oval shaped tablets debossed with SG 160; SG 161; or SG 162. You can also contact the pharmacy that filled your prescription to see if you received affected product.

If you received product affected by this recall, please contact the pharmacy that filled your prescription for further instructions.

Please note: The United States Food and Drug Administration (FDA) recommends that members that are taking any recalled Irbesartan tablets should continue taking their current medicine until they receive replacement product or their doctor prescribes a different medicine to treat their condition.

Please call your doctor right away for advice if you may be using affected product or if you do not know if you used affected product or not. Your doctor is familiar with your medical history and can suggest the best treatment option for you. If you need a prescription for a different medicine, please call your doctor.

CVS Caremark Response: If you are currently taking Irbesartan tablets, please call a Customer Care representative toll-free at 1-866-823-5184. We will give you more information and help with arrangements for the return and replacement of any affected product.

For more information about the Westminster product recall, please call Westminster Pharmaceuticals toll-free at 1‑888‑354‑9939, 9:00 am to 5:00 pm (ET). For more

information about the Golden State product recall, please call Golden State Medical Supply toll-free at 1-800- 284-8633 ext. 215, 7:30 am to 4:00 pm (PT). You may also call the United States Food and Drug Administration (FDA) toll-free at 1‑888‑INFO-FDA (1‑888-463-6332) or visit https://www.fda.gov.

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