Overdose of opioid pain medications such as hydromorphone may lead to life-threatening consequences, including slowed breathing, low blood pressure and reduced heart rate, the FDA said.
Hospira began the recall on Thursday after a complaint that one Carpuject — the drug delivery system — contained more than the intended 1ml labeled fill volume.
The company said it has not received any reports of adverse events related to the affected lot.
The number of the affected lot is 12720LL and it was distributed between March and May 2012.
(Reporting by Prateek Kumar in Bangalore; Editing by Saumyadeb Chakrabarty)
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