Important FDA Drug Recall Information

You may have recently heard of the FDA recall on a handful of common blood pressure medications. We want to ensure our patients understand this recall.

What medications were recalled?

On November 27, 2018, Teva Pharmaceuticals issued a voluntary recall of the following:

• – Amlodipine/Valsartan combination tablets
• – Amlodipine/Valsartan/Hydrochlorothiazide combination tablets

Please note, only specific manufacturers of the above combination products were affected by the recall. Amlodipine (Norvasc® is the brand name) is NOT part of the recall.

Additionally, the FDA recently recalled:

• – One specific lot number of a Sandoz, Inc. Losartan/Hydrochlorothiazide combination tablet on November 8, 2018.
• – Several manufacturers of Valsartan and Valsartan/Hydrochlorothiazide combination tablets on July 13, 2018.

These medications were recalled due to an impurity, known as NDEA, that has been classified as a possible human carcinogen (a substance that could cause cancer).

The FDA has advised that these medications be continued until a suitable replacement is given.

How do pharmacies handle recalls?

Ensuring that you take medications that are safe is a pharmacist’s most important job.

When a medication is recalled:

• – Pharmaceutical manufacturers and distributors will inform pharmacies about specific products that are being recalled, including lots that were impacted.
• – The FDA will often release information about the recall as well as guidance for how patients, providers, and pharmacies should proceed.
• – Pharmacies will remove all products affected by a recall from inventory.
• – Pharmacies will look through records to find patients who may be affected and contact them.
• – Pharmacists will notify providers of any recalls that may affect their patients and attempt to find a replacement for the recalled medication, if applicable.

If you have questions or concerns regarding this recall, please feel free to call your doctor or our Sona team! The Sona phone number is 828-298-3636.

Thank You.

Deven Jackson

https://www.fda.gov/Safety/Recalls/ucm626802.htm