The US Food and Drug Administration (FDA) has issued an urgent recall for a specific batch of the blood pressure drug valsartan, sold under the brand name Diovan by Novartis. The recall is due to the drug not meeting dissolution specifications, which affects its effectiveness and could lead to harmful consequences for patients.
Class II Recall Details
The FDA has classified this as a Class II recall, meaning exposure to the drug may lead to “temporary or medically reversible adverse health consequences.” The impact is expected to stop once patients stop taking the medication, but those who have the affected batch are urged to discard it immediately.
The recalled batch carries the identifier AV5913C on the packaging and includes packages of 90 160-mg tablets with an expiration date of June 2027. The drug was manufactured by Pantheon Manufacturing Services in Greenville, North Carolina, and distributed by Novartis Pharmaceutical Corp. in Hanover, New Jersey. The FDA noted that the tablets have been distributed nationwide in the US.
UK Ramipril Shortage
Novartis initiated the recall on August 4. This comes as the UK faces a 'serious shortage' of blood pressure drugs. A review by MediWatch on August 4 highlighted a shortage of Ramipril 1.25mg capsules across England, Scotland, Wales, and Northern Ireland.
The Department of Health and Social Care (DHSC) issued a Serious Shortage Protocol on April 22, which was extended beyond May 29. This protocol limits community pharmacies to dispensing a maximum of one month's supply per prescription, even for patients who usually receive two to three months' supply.
