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A recent recall of a medication taken by more than 1 million Americans has been upgraded to a class II over concerns the drug does not work properly.
The recall of Chlorthalidone tablets was first issued June 5 and classed on June 22 due to ‘failed dissolution specifications.’
This means there is a problem with how the medication dissolves in the body, which could indicate the drug dissolves too slowly, too quickly or not fully.
This could then mean the amount of active drug released into the body is either more or less within a certain timeframe.
If a medication does not dissolve properly, it may not work as intended, which could pose serious risks to people taking it to control a medical condition.
When a drug dissolves too slowly, the body may not absorb enough and symptoms may not be treated or controlled properly.
If it dissolves too fast, there is the potential for side effects or safety issues.
Chlorthalidone is a prescription drug used to treat high blood pressure and reduce excess fluid retention caused by heart, liver or kidney conditions.
If a medication does not dissolve properly, it may not work as intended, which could pose serious risks to people taking it to control a medical condition
About 5 million prescriptions are written for about 1.5 million Americans per year.
A class II recall indicates: ‘A situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.’
The recall applies to 100- and 1,000-tablet bottles of 25 mg pills with the expiration date of April 2027.
The medication is manufactured by Inventia Healthcare Limited and distributed by Rising Pharma Holdings, Inc.
Approximately 11,460 bottles have been recalled.
The 100-tablet bottles have the NDC 64980-599-01 and batch code RISA24001 and the 1,000-tablet bottles have the NDC 64980-599-10 and batch code ISB24002.
The FDA has not issued guidance on what people should do who take the medication but in similar previous recalls, it has been advised for patients to urgently contact their doctors.
If someone is taking the drug for high blood pressure and it does not work properly, they could be at risk of uncontrolled hypertension.
Untreated high blood pressure can cause serious complications, such as stroke, heart attack, heart failure, kidney damage and blood vessel damage.
If a person is taking it for fluid retention and their edema goes untreated, they could suffer worsening swelling in the legs, around the lungs and in their abdomen, shortness of breath and strain on their kidneys or heart.
Patients are also at risk of side effects if the drug doesn’t work correctly, including electrolyte imbalances, low potassium, low sodium and low magnesium.
This may lead to muscle weakness, fatigue, cramping, irregular heartbeat, confusion, seizures, headaches, reduced kidney function, low blood pressure and high blood sugar.
