A nationwide recall has been issued for a commonly used drug in hospitals over a mislabeling incident which could result in overdoses and even death.
Bags of IV drugs manufactured by California-based ICU Medical are being recalled for being double the dose they are labeled as.
The firm says lots of its potassium chloride were correctly printed with 20 mEq (1,500mg) on the bags, however overwraps incorrectly state the amount is 10 mEq (750mg).
Potassium chloride – administered intravenously – is used to treat hypokalemia, a condition in which the body’s potassium levels are too low.
It can also be used to replenish fluids and electrolytes.
Hypokalemia affects up to 21 percent of hospitalized patients in the US, which equates to around 7 million people each year.
ICU Medical says if medical staff incorrectly give patients the IV bags working from the wrong 10 mEq labels, they could suffer an overdose.
It warns that this could result in a range of side effects including muscle weakness, paralysis progressing from the lower limbs to the upper body, vertigo, mental confusion, hypotension, or death from cardiac arrest.
Bags of IV drugs manufactured by California-based ICU Medical are being recalled for being double the dose they are labeled as
ICU Medical says lots of its potassium chloride were correctly printed with 20 mEq (1,500mg) on the bags, however overwraps incorrectly state the amount is 10 mEq (750mg)
High risk patients – such as premature infants, those with a history of irregular heartbeat or chronic kidney disease – are more prone ‘potentially fatal outcomes’, the company says.
Undiluted potassium chloride is one of the components of the three-shot lethal injection.
The shot – given to death row prisoners – comprises three chemicals: midazolam, to sedate; vecuronium bromide, to paralyze the muscles; and potassium chloride, to stop the heart.
The potassium chloride component of the injection consists of two 120mg syringes.
When potassium chloride is administered via an IV drip, it is diluted in water and administered at a slow rate over the course of a day, to prevent sudden death.
To date, ICU Medical has not received any reports of adverse events associated with the mislabeled IV bags.
The recalled product can be identified by the lot number 1023172 and it has an expiration date of January 2026.
ICU Medical says it is notifying its customers, including distributors, of the recall by letter.
It is also arranging for the return of all recalled product.
All health care professionals have been instructed to should stop using the mislabeled IV bags immediately and to return them to place of purchase.
Meanwhile, consumers who have experienced any problems that could be related to taking or using the drug product are advised to seek medical advice.
