Update: Prescription Medication Recall - Cigna

Cigna Pharmacy Management?

Update: Prescription Medication Recall

Valsartan/HCTZ, valsartan/amlodipine and valsartan/amlodipine/HCTZ

Updated information about this recall

Your safety, health and well-being are important to us. We want to let you know that on August 24, 2018, the U.S. Food and Drug Administration (FDA) expanded its voluntary, nationwide recall of certain medications containing the ingredient valsartan. The affected medications are made and/or distributed by Camber Pharmaceuticals Inc. (also labeled as AvKARE or AvPAK), Teva Pharmaceuticals USA (labeled as Major Pharmaceuticals, Actavis, LLC and AvKARE), Prinston Pharmaceuticals Inc. (labeled as Solco Healthcare LLC), and Torrent Pharmaceuticals Limited. We've included an updated list of the medications affected by this recall at the end of this notice.

Why these medications were recalled

A small amount of a substance called N-nitrosodimethylamine (NDMA) was found in certain medications containing valsartan. These medications were made and/or distributed by Camber Pharmaceuticals Inc. (also labeled as AvKARE or AvPAK), Teva Pharmaceuticals USA (labeled as Major Pharmaceuticals, Actavis, LLC and AvKARE), Prinston Pharmaceuticals Inc. (labeled as Solco Healthcare LLC), and Torrent Pharmaceuticals Limited. Because NDMA may cause cancer in humans, these manufacturers recalled certain valsartan medications. It's important to know that as of the date of publication, neither the FDA nor the drug manufacturers have said they received complaints or information about medical illness or harmful effects caused by the recalled medications.

What valsartan is used to treat

Valsartan is a generic prescription medication commonly used to treat high blood pressure and heart failure. Valsartan may also be used in combination with amlodipine or amlodipine plus hydrochlorothiazide to control high blood pressure.

Please check the label on your pill bottle to find out if your medication was recalled

Look for the information below. Then compare it to the information listed in the chart at the end of this notice. If it matches, your medication was recalled. If it doesn't match, your medication wasn't recalled. To help you know where to look, we've included a sample label below. If you still can't find this information, please call the pharmacy you used to fill your prescription.

? Medication name, dosage and/or count (amount)

? Name of the company who made and/or distributed the medication

? NDC number ? Lot number

NDC number

Medication name and dosage

Name of the company who made/distributed the medication

Medication count (Amount)

Lot number

Here's what you can do if your medication was recalled

? Call the company that made and/or distributed the medication to learn more about the recall and what you may need to do with the medication. > Actavis LLC: - By phone: 888.838.2872 and press "3" from the list of options. They're available MondayFriday, 9:00 am-5:00 pm EST. You can also leave a voicemail at that number. - By email: druginfo@ > AvKARE: - By phone: 855.361.3993 - By email: DrugSafety@ > Camber Pharmaceuticals Inc. (Qualanex, LLC): - By phone: 800.505.9291. They're available Monday-Friday, 9:00 am-5:00 pm CST. - By email: recall@ > Major Pharmaceuticals: 800.616.2471 and press "1" from the list of options. They're available Monday-Friday, 8:00 am-8:00 pm EST. > Solco Healthcare LLC: 888.679.5120. They're available Monday-Friday, 9:00 am-5:00 pm EST. > Torrent Pharmaceuticals Limited: - By phone: 800.912.9561. They're available Monday-Friday, 8:00 am-5:00 pm EST. You can also leave a voicemail at that number. - By email: Medinfo.Torrent@

? Call your doctor's office to find out how this affects your health and/or treatment. We're also letting health care professionals who have patients with Cigna pharmacy benefits and have been prescribed valsartan know about this recall. Ask your doctor's office if there's an alternative medication you can take. Because valsartan is used to treat serious conditions, the FDA suggests you continue taking the recalled medication until you speak with your doctor and/or start taking an alternative medication.

? Go to the U.S. Food and Drug Administration (FDA)'s website to learn more about the recall and next steps.

We're here if you need us

Please call your doctor's office if you have questions about how this recall affects your health and/or treatment.

If you're a Cigna customer and have a question about your coverage or benefits, please call the number on the back of your Cigna ID card. We're available anytime, 24/7/365.

918325b Updated Valsartan_Amlodipine_Recall_Posted Online_09/18 ? 2018 Cigna.

Updated list as of August 24, 2018 ? these are the medications containing valsartan that are affected by this recall:

Actavis, LLC Medication/Dosage/Amount

Valsartan tablets 40MG 90CT Valsartan tablets 40MG 30CT Valsartan tablets 80MG 1000CT

Valsartan tablets 80MG 90CT

Valsartan tablets 160MG 1000CT Valsartan tablets 160MG 90CT Valsartan tablets 320MG 500CT Valsartan tablets 320MG 90CT

Valsartan and Hydrochlorothiazide tablets 80/12.5MG 90CT

Lot number 1196934M 1238462M 1268429A 1196936A 1238463A 1270617A 1177114A 1219360M 1250706A 1175947M 1175948M 1177115A 1219361A 1240434M 1250704M 1175922M 1220826M 1236294M 1240427M 1270616A 1177880A 1220831A 1263941A 1208000M 1208001M 1240425A 1208002A 1247282M 1263944M 1191191M 1191192M 1191193M 1191194M 1191195M 1238466M 1238467M 1253261M 1256125M 1277709M

NDC number 0591-2167-19 0591-2167-30 0591-2168-10 0591-2168-19

0591-2169-10 0591-2169-19 0591-2170-05 0591-2170-19

0591-2315-19

Actavis, LLC, continued Medication/Dosage/Amount

Valsartan and Hydrochlorothiazide tablets 160/12.5MG 90CT

Valsartan and Hydrochlorothiazide tablets 160/25MG 90CT Valsartan and Hydrochlorothiazide tablets 320/12.5MG 90CT

Valsartan and Hydrochlorothiazide tablets 320/25MG 90CT

Lot number 1191160M 1191161M 1191162A 1219363M 1219364M 1219365A 1225613A 1233944M 1233945M 1253253M 1253254M 1191164M 1191165M 1191166M 1191167A 1225612M 1250717M 1256111M 1288798M 1191185M 1191186M 1225615M 1233948M 1250718M 1253257M 1191188M 1191189M 1191190M 1199220M 1217576M 1217577M 1217578M 1220832M 1220833M 1247283M 1247284M 1247285M 1247286M 1247287A 1280632M 1280633M

NDC number 0591-2316-19 0591-2317-19 0591-2318-19

0591-2319-19

AvKARE

Medication/Dosage

Valsartan and Hydrochlorothiazide tablets 80MG/12.5MG

Valsartan and Hydrochlorothiazide tablets 160MG/12.5MG

Valsartan and Hydrochlorothiazide tablets 320MG/12.5MG

Valsartan and Hydrochlorothiazide tablets 160MG/25MG Valsartan and Hydrochlorothiazide tablets 320MG/25MG

Lot number 17349 18395 19221 20029 20158 20843 21411 17325 17856 18396 18702 19020 19222 20030 20381 17780 18029 18398 18723 19017 19224 20032 20289 21076 21382 17307 17857 18397 18722 19016 19223 20031 20382 21281 17308 18158 18539 19021 19225 20033 20290 20565 21369

NDC number 42291-884-90 42291-885-90 42291-886-90 42291-887-90 42291-888-90

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