A batch of the blood pressure drug valsartan, sold under the brand name Diovan by Novartis, is being urgently recalled because it may not dissolve correctly, which could lead to harmful health consequences for patients.
Reason for the recall
The recall was triggered by failed dissolution specifications, meaning the drug does not dissolve as intended, reducing its effectiveness. Diovan is an angiotensin II receptor blocker used to treat hypertension and heart failure, and it can also be prescribed to patients after a heart attack.
The US Food and Drug Administration (FDA) has classified the notice as a Class II recall. This indicates that exposure to the drug may lead to “temporary or medically reversible adverse health consequences.” These effects are not expected to persist after patients stop taking the medication, but they are likely to be harmful.
Affected batch and distribution
The recalled batch is labelled AV5913C and includes packages of 90 160-mg tablets with an expiry date of June 2027. The tablets were manufactured by Pantheon Manufacturing Services in Greenville, North Carolina, and distributed by Novartis Pharmaceutical Corp. in Hanover, New Jersey. According to the FDA, the drugs were distributed nationwide in the US.
The recall was initiated by Novartis on August 4. In the UK, there is currently a shortage of the country's most-prescribed blood pressure drug. According to MediWatch's review on August 4, Ramipril 1.25mg capsules are in “serious shortage” across England, Scotland, Wales and Northern Ireland.
UK shortage context
The Department of Health and Social Care (DHSC) issued a Serious Shortage Protocol on April 22 and extended it beyond May 29, which limits community pharmacies to dispensing a maximum of one month's supply per prescription, even for patients who usually receive up to three months' supply.
