The Importance of Labeling

Labeling issues continue to plague the medical device and pharmaceutical industry. The FDA recently released a statement regarding a medication recall as a result of a labeling error.

CBS News reports, “Accord Healthcare Inc. is voluntarily recalling one lot of 12.5 mg hydrochlorothiazide tablets after a 100-count bottle of the drug was found to contain 100 tablets of another drug, spironolactone.”

While both medications are used in treating high blood pressure, taking spironolactone instead of hydrochlorothiazide can increase risk of hyperkalemia, an unsafe increase in potassium levels. The result of hyperkalemia is “adverse events that range from limited health consequences to life-threatening situations in certain individuals.”

USA Today writes, “The effects of mixing up the medications — both help bodies get rid of extra salt and water — depend on the individual but can range from “limited” to “life-threatening,”

Accord Healthcare Inc., was notified of the label mix-up from a complaint reported from a pharmacy. The company has recalled a single lot of the drug, labeled PW05264 and has reached out to wholesalers, distributors and retailers by letter and is arranging for return of all recalled products.

So far, there have been no reported illnesses, though Accord Healthcare Inc., is taking a proactive approach to handling the mislabeling error.

The FDA says, “The hydrochlorothiazide tablets are light orange to peach colored, round, and debossed with an “H” on one side and a “1” on another side. If the tablets in a bottle of Accord hydrochlorothiazide 12.5 mg do not match this description, or if consumers are unsure, they should return to their pharmacy or healthcare provider for confirmation.”

Q1’s Device & Diagnostic Labeling Workshop Intensive on September 20 in San Diego, CA will address the importance of clear labeling practices, EU MDR impact on labeling, as well as understanding ELS software. Click here to reserve your spot today!