Key Takeaway:
- FDA classifies the recalled chlorthalidone as a Class II recall after failed dissolution testing.
- The recall affects more than 13,500 bottles distributed nationwide.
- The recall follows a similar Inventia chlorthalidone recall reported in July.
Federal regulators have classified a nationwide recall of more than 13,500 bottles of Inventia Healthcare’s chlorthalidone as Class II after the blood pressure medication failed dissolution testing.
FDA Flags Blood Pressure Medication Testing Failure
The recall covers 13,567 bottles of chlorthalidone tablets, USP, 25 milligrams, packaged in 100-tablet bottles and distributed nationwide, according to FDA recall information. The company initiated the recall Sept. 3 after the tablets failed required dissolution specifications.
The FDA classified the recall Sept. 17. Under the agency’s definition, a Class II recall applies when use of a recalled product “may cause temporary or medically reversible adverse health consequences” or when the likelihood of serious consequences is remote.
The classification does not mean the FDA has determined that serious harm has occurred. FDA says recall classifications reflect the relative health hazard associated with a recalled product.
The affected medication is chlorthalidone, a diuretic commonly used to help control high blood pressure. The recalled product is identified as NDC 64980-599-01, with lot RISA24002 and an expiration date of April 2027, according to recall information.
Dissolution Testing Checks Drug Release
Dissolution testing measures how quickly and how much a drug is released from a tablet or other dosage form. Pion Inc., a pharmaceutical analytical technology company, describes it as a test that measures “the extent and rate of drug release” and helps determine whether a product meets quality specifications.
A failure in dissolution testing can raise concerns about whether a tablet releases its active ingredient as expected. The FDA-approved drug information for Inventia also identifies the company as a manufacturer involved in dissolution testing for pharmaceutical products.
The FDA’s enforcement reporting system lists recall classifications after reviewing information about the potential public health risk. The agency notes that classifications can be assigned after a firm has already initiated a voluntary recall.
The current recall is separate from another Inventia chlorthalidone recall reported earlier this year. NewsNation reported in July that more than 11,000 bottles of the company’s 100- and 1,000-tablet chlorthalidone products were recalled for the same dissolution-testing issue.
Recall Follows Earlier Chlorthalidone Action
The September recall of blood pressure medication brings renewed attention to quality testing for drugs used to manage chronic conditions.
FDA guidance says Class II recalls are distinct from Class I recalls, which involve a reasonable probability of serious adverse health consequences or death. Class III recalls apply when use of a recalled product is not likely to cause adverse health consequences.
Patients who believe they have a recalled product should verify the product and lot information against the FDA recall notice and contact a health care professional or pharmacist for guidance before making changes to prescribed treatment.
The FDA maintains recall information through its Enforcement Reports and drug safety resources.
