Authorities in America and Canada have pulled patches containing the prescription painkiller fentanyl from shelves over fears patients could accidentally overdose.
Some of the patches may have a cut in the lining of the internal reservoir where the drug is stored in gel form.
If the fentanyl leaks on to the packaging, a patient or carer could come into direct contact with the opioid, causing breathing difficulties and a potentially fatal overdose.
All of the patches were manufactured by ALZA, an affiliate of PriCara, which is itself a division of Ortho-McNeil-Janssen Pharmaceuticals.
PriCara sells the drug in the United States under the brand name Duragesic, while Sandoz markets a generic version.
The Food and Drug Administration issued its second warning about the drug in two years back in December.
It is intended for chronic pain in people used to taking narcotics, such as cancer patients.
But the FDA found some instances where doctors prescribed it for headaches or postsurgical discomfort.
PriCara said that around two patches out of every million included in the recall have the defect that causes the leak.
All 25-microgram-per-hour patches with expiration dates on or before December 2009 are subject to the move.
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