Drugmaker KVK Tech pulls batch of beta blockers after finding opioid tablet on packaging line

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来源: FiercePharma

For patients, an opioid tablet would be tough to distinguish from the intended betaxolol prescription.

After workers at Pennsylvania-based KVK Tech found a stray Oxycontin tablet on the packaging line for a batch betaxolol tablets, the company is recalling the batch as a precautionary measure.

The Oxycontin pill was found during a line clearance procedure after the beta blockers were already packed up. So far, the generics maker hasn’t heard reports of a foreign tablet appearing in its medicine, according to an FDA statement on the recall.

Beta blockers are prescribed for heart problems such as rhythm disorders, angina and hypertension. The meds slow down a patient’s heart rate, making for a dangerous situation if a patient were to accidentally consume an opioid in addition to their beta blockers.

The two tablets look almost identical, featuring only minor differences that a patient likely wouldn’t catch, the FDA said.

The affected batch has an expiration date of June 2027. The company has notified its distributors and customers and believes that a “small number” of bottles may have been sent out to retail pharmacies.

While the Oxycontin mix-up is unique, the company has run into manufacturing issues before. In 2020, the FDA issued KVK Tech a warning letter after finding the company failed to meet testing standards for a weight loss medicine.

The same letter detailed issues with the plant’s investigation of foreign particles found in a lot of an ADHD drug.

Later that year, KVK received another letter for skirting cleaning protocols, among other shortfalls.

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