Announcement this week of the recall of a batch of blood pressure medication from Accord Healthcare Inc (read the recall notice here) reminds us why Labeling and Packaging is one of the 6 critical GMP systems. The drug product (hydrochlorothiazide HCl, a commonly used medicine for lowering blood pressure) appears from the initial investigation to have been mis-labeled as spironolactone, a medicine used to treat congestive heart failure. The risk to patients who take hydrochlorothiazide, which also acts to reduce the loss of potassium from the body, could be increased blood potassium level, potentially resulting in mild to serious negative effects on the heart and digestive, nervous, and muscle systems. Something as simple as applying the label for one drug product incorrectly to a batch of another drug product could have a widespread effect. Fortunately, no adverse events have been reported for this batch.

Read more about the 6 systems regulations for the US here.

Text Copyright © 2018 Katrina Rogers