Important Recall Message: Diovan® (valsartan) Tablets 160 mg, isolated lot recall due to stray tablets

Important Recall Message:

Novartis, working with the FDA, is doing this voluntary recall because it was noticed that one of the larger Diovan 160 mg wholesale bottles that was shipped to our pharmacy contained three (3) tablets of a different product, called Diovan HCT® 320/12.5 mg (valsartan/hydrochlorothiazide).

As a precaution, Novartis has requested that we recall all prescriptions that were filled using tablets from this lot.

What should you do?

  • Do not stop taking your medication.
  • Replacement supplies of Diovan 160 mg Tablets will be provided to impacted patients.
  • A pre-addressed, postage paid return envelope will be provided to impacted patients to return the medication affected by this recall.
  • If you have any questions related to this recall, call Novartis directly at (877) 395-2334.
  • If you have questions about the prescription you are taking, please discuss this with your doctor. Your doctor has also been notified about this recall.

According to the Novartis assessment, this is an isolated event and the recall of prescriptions to patients is being conducted as a precaution.

What Does This Mean for You?
Diovan HCT tablets have different ingredients and are a different strength than Diovan 160 mg. Although unlikely, a patient who was prescribed Diovan 160 mg, but took Diovan HCT 320/12.5 mg might experience a change in their medical condition. A Diovan dose higher than what was prescribed could cause a greater decrease in blood pressure than anticipated. This could result in light-headedness, dizziness, or passing out. Also, in a patient with an allergy to sulfonamide drugs, taking Diovan HCT could cause an allergic reaction. Hydrochlorothiazide (the HCT component in Diovan HCT) can also interact with other drugs that you may be taking. Suddenly stopping Diovan without talking to your doctor can also cause serious health risks. If you have questions about the prescription you are taking, please consult your doctor.

How can you tell the difference between Diovan Tablets and Diovan HCT tablets?
Diovan HCT and Diovan tablets have different shapes and colors. Diovan HCT 320/12.5 mg Tablets are pink, oval shaped tablets with beveled edges, and are marked "NVR" on one side and "HIL" on the other side. The medication that has been prescribed for you, Diovan 160 mg, are gray-orange color, almond shaped with beveled edges, and marked "DX" on one side and "NVR" on the other side.

What is Diovan and Diovan HCT?
Diovan and Diovan HCT are prescription medicines used to treat high blood pressure in adults. Diovan HCT may be used when one medicine to lower your high blood pressure is not enough. Diovan HCT may also be used as the first medicine if your doctor decides you are likely to need more than one medicine to lower your high blood pressure.

Diovan is used to treat heart failure in adults. In these patients, Diovan may lower the need for hospitalization that happens from heart failure. Diovan HCT is not approved for this use.
Diovan is used in adults to improve the chance of living longer after a heart attack (myocardial infarction). Diovan HCT is not approved for this use.

As always, contact your doctor if you experience any adverse side effects.

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