Accord Healthcare Inc., a global provider of generic and specialty pharmaceuticals, is voluntarily recalling one lot of 100-count 12.5 (milligram) mg hydrochlorothiazide tablets. Contrary to what the label says, the bottles actually contain another drug, spironolactone. Accord was made aware of the mix-up from a product complaint reported by a pharmacy, according to the FDA. Initial and interim investigations have been conducted at the manufacturing site, and according to Accord, no other lots of hydrochlorothiazide were affected by the error. “Spironolactone and hydrochlorothiazide are two very different medications, although both can be used to treat high blood pressure,” says Ann Marie Navar, MD, PhD, a cardiologist at Duke Health in Durham, North Carolina. If a person uses spironolactone tables instead of hydrochlorothiazide, he or she could experience adverse events that range from “limited health consequences” to “life-threatening situations,” according to the FDA statement. Currently, Accord has not received any reports of adverse events or illnesses related to this recall. “The worst-case scenario would be if a patient had an allergy to spironolactone and received this by mistake — fortunately that would be rare,” says Dr. Navar. “The biggest concern I have relates to the potential for dangerously high potassium levels,” she says. Spironolactone can raise blood potassium levels, particularly in people with reduced kidney function or who are on other therapies that may increase potassium, according to Navar. “High potassium can cause life-threatening heart-rhythm problems and is a medical emergency,” she says. This condition, called hyperkalemia, often doesn’t have any obvious symptoms, even with dangerously high levels of potassium, says Navar. “In general, as with most blood pressure medications, people usually cannot tell if they have taken spironolactone.” Hydrochlorothiazide is a generic drug and is manufactured and distributed by several different drug companies. Accord Healthcare’s 12.5 mg tablets are light orange– to peach-colored, round, biconvex tablets debossed with “H” on one side and “1” on the other side. If you have a prescription of Accord hydrochlorothiazide and the tablets do not match this description or the image depicted in the above link, you should return it to your pharmacy or doctor to confirm that you have the right medicine. If you have the medication from the lot that is under recall (Lot PW05264 – 46632 Bottles, NDC 16729-182-0) you should return the product to the pharmacy. People who experience any potential problems or symptoms as a result of taking or using the mislabeled drug should contact their healthcare provider right away. Questions about the recall itself should be directed to Accord Healthcare by calling 855-869-1081, Monday through Friday, from 8 a.m.–5 p.m. EST or by sending an email to rxrecalls@inmar.com.
