<\/p>\n
A prescription drug recall can be easy to miss, especially when it does not come with a major public announcement.<\/p>\n
But for patients who take medication every day, even a technical-sounding recall can matter. <\/p>\n
Many people rely on prescription drugs not for short-term symptoms, but to manage ongoing health conditions that require consistent dosing.<\/p>\n
That is why a new update from the U.S. Food and Drug Administration (FDA) is drawing attention.<\/p>\n
The FDA has updated a nationwide recall of a blood pressure medication to Class II, giving patients, pharmacies, and health care providers a clearer picture of the potential risk associated with the product.<\/p>\n
The recall involves Chlorthalidone Tablets, USP, 25 mg, a prescription medication used to treat high blood pressure and fluid retention.<\/p>\n
Chlorthalidone is a diuretic, often called a \u201cwater pill.\u201d It helps the kidneys remove extra water and salt from the body through urine, which can help lower blood pressure and reduce swelling.<\/p>\n
Because the drug is used to manage conditions that can require long-term treatment, patients should not stop taking it without first speaking with a doctor or pharmacist.<\/p>\n
FDA recall covers 11,460 bottles of Chlorthalidone<\/p>\n
The FDA Enforcement Report lists the recall for Chlorthalidone Tablets, USP, 25 mg, in 100-tablet and 1,000-tablet bottles.<\/p>\n
The medication was manufactured by Inventia Healthcare Limited in India and distributed in the U.S. by Rising Pharma Holdings, Inc., in East Brunswick, N.J., according to the FDA product details.<\/p>\n
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The recall covers 11,460 bottles distributed nationwide.<\/p>\n
The affected 100-tablet bottles carry NDC 64980-599-01 and batch number RISA24001.\u00a0The affected 1,000-tablet bottles carry NDC 64980-599-10 and batch number RISB24002.<\/p>\n
Both recalled batches have an expiration date of April 2027.<\/p>\n
The FDA lists the reason for the recall as \u201cfailed dissolution specifications.\u201d<\/p>\n
That does not mean the recall involves contamination or a labeling mistake. Instead, it means the tablets failed to meet the required standards tied to how the medication dissolves.<\/p>\n
For a prescription drug, that can matter because dissolution testing helps determine whether a tablet releases medicine as expected after it is taken.<\/p>\n
The recall is voluntary and firm-initiated, according to the FDA record. The agency says the company initially notified consignees or the public by letter.<\/p>\n
The recall was initiated on June 5 and classified by the FDA on June 22. The recall remains ongoing, and the FDA lists no termination date.<\/p>\n
No press release was issued for the recall, according to the FDA record.<\/p>\n
The FDA recalls Chlorthalidone Tablets, a blood pressure medication.<\/p>\n
saifulasmee chede / Getty Images<\/p>\n
Class II recall gives patients new details<\/p>\n
The FDA originally listed the recall as \u201cnot yet classified,\u201d but the agency has now updated it to Class II.<\/p>\n
A Class II recall is not the FDA\u2019s highest-risk category, but it still signals a potential health concern.<\/p>\n
The FDA defines a Class II recall as one in which use of or exposure to a product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.<\/p>\n
For patients, the classification provides more context about the risk level associated with the recalled medication.<\/p>\n
The chlorthalidone recall comes amid heightened consumer attention to blood pressure medication recalls.<\/p>\n
People reported earlier this month that another blood pressure drug, Amlodipine and Olmesartan Medoxomil Tablets, was recalled in May after more than 15,000 bottles were affected by a separate failed dissolution issue.<\/p>\n
The latest FDA update adds a new development to the chlorthalidone recall: the agency has now assigned it a Class II classification.<\/p>\n
Related: Kroger stock slide reveals bigger grocery problem<\/p>\n
#FDA #recall #raises #concern #blood #pressure #drug<\/p>\n","protected":false},"excerpt":{"rendered":"
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