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Thursday, 25.04.2024, 16:04
Printing house blamed for morphine packaging mix-up in Lithuania
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"A mix-up of boxes in the printing house that produced them and insufficient control actions were identified as the reason behind the error," it said, citing the results of an in-house probe at Santonika, the manufacturer of the medications.
The agency itself carried out two unscheduled inspections of Santonika in July and August.
The first inspection revealed "a lack of control during the production process" and the second one was conducted to see if the company had eliminated the shortcomings.
Santonika has carried out an audit of the printing house and recommended that it step up error prevention. It has also tightened its own quality control procedures.
Almost 2,000 packages of morphine produced by Santonika were withdrawn from the market in late July after it was established that morphine ampoules had been put into packages labelled as atropine sulfate.
This was the first such incident ever reported in Lithuania.
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