WASHINGTON (WOWO) — More than 25,000 bottles of a prescription blood pressure medication have been recalled after the tablets failed testing designed to ensure the drug dissolves properly.
The recall involves 25-milligram chlorthalidone tablets manufactured by Inventia Healthcare Limited, which is based in India.
According to the Food and Drug Administration, the tablets failed dissolution specifications. That testing determines how a medication releases its active ingredient after it is taken according to 21-Alive.
A problem with dissolution can affect how quickly or how much of the active ingredient is absorbed by the body, potentially affecting how well the medication works.
The total number of recalled bottles comes from two separate recalls issued this year .
The first recall involved 11,460 bottles and was announced in June. A second recall involving 13,567 bottles was issued in September, bringing the total to 25,027 bottles.
The recalled medication is chlorthalidone tablets, USP, 25 milligrams. The affected products were packaged in bottles containing either 100 or 1,000 tablets and have an expiration date of April 2027.
Chlorthalidone is a diuretic commonly prescribed to treat high blood pressure. The medication helps the kidneys remove excess salt and water from the body, which can reduce blood pressure.
The FDA classified the recalls as Class II.
According to the FDA, a Class II recall involves a product that could cause temporary or medically reversible health consequences, or when the possibility of serious health consequences is considered remote.
The concern in this case centers on the tablets’ ability to dissolve according to their specifications.
Patients who take chlorthalidone should not stop taking the medication without first talking with their health care provider.
Stopping blood pressure medication suddenly or without medical guidance can create its own health risks.
Patients should check their prescription bottles to determine whether they have the affected medication. Anyone who is unsure whether their prescription is part of the recall can contact a pharmacist or health care provider for assistance.
The recall does not apply to every chlorthalidone prescription. It is limited to the specific products and lots identified by the FDA.
The agency continues to monitor recalled medications and works with manufacturers to remove affected products from the market.
For anyone taking chlorthalidone, the FDA’s advice is straightforward: check whether the prescription is affected, but do not discontinue treatment without first consulting a health care professional.
