FDA chlorthalidone dissolution testing recall: the U.S. Food and Drug Administration classified a voluntary recall of certain chlorthalidone 25 mg tablets as Class II after the tablets failed dissolution specifications. The action covers 13,567 bottles and was tied to Inventia Healthcare Limited.
Patients who use the affected medicine should check the pharmacy label or original bottle for the National Drug Code, lot number, and expiration date. The FDA says people should contact a pharmacist or healthcare provider for instructions and help obtaining a replacement, and they should not stop taking chlorthalidone on their own.
Inventia Healthcare Limited lots
The recall includes lot RISA24002, with NDC 64980-599-01, in a 100-tablet bottle with an expiration date of 04/2027. The additional lots listed in the recall include RISA24001, also tied to NDC 64980-599-01 and a 100-count bottle, and RISB24002, tied to NDC 64980-599-10 in a 1,000-count bottle.
Inventia Healthcare Limited initiated another recall on Sept. 3 involving an additional lot. Earlier this year, the company had already recalled certain lots of chlorthalidone tablets, and the FDA classified the recalls as Class II.
FDA Class II finding
Dissolution testing measures how a drug releases its active ingredient. When a tablet does not meet those specifications, it may not release the medication as intended. Chlorthalidone is a prescription diuretic used to treat high blood pressure and fluid retention, so the failure goes to how reliably the tablets may work for patients who depend on them.
The FDA uses a Class II classification when exposure to a recalled product may cause temporary or medically reversible health problems, or when the likelihood of serious adverse health consequences is remote. For patients, the practical step is straightforward: compare the label or bottle against the listed NDC and lot information before taking more tablets.
Chlorthalidone patient checks
The NDC is a unique three-segment identifier used for drugs marketed in the United States. That makes the bottle label the fastest way to separate an affected prescription from one that is not part of the recall, especially when the medication was dispensed in a 100-count or 1,000-count container.
Because the tablets may not dissolve properly, the recall affects whether the medicine is released as intended. Patients with one of the listed lots should treat the pharmacy label as the starting point, then contact a pharmacist or healthcare provider before making any change to treatment.
