Drug Company Expanding Recall of Pain PatchesApr 4, 2004 | AP Janssen Pharmaceutica Products is expanding a recall of 75 microgram-per-hour prescription Duragesic patches, which are used to treat moderate to severe chronic pain.
Janssen recalled a single manufacturing lot of 440,000 patches in February after determining that some of them were leaking medication along one edge.
The Johnson & Johnson subsidiary said Monday that it is adding patches from four additional manufacturing lots to the initial lot included in the original recall.
A total 2.2 million patches from five lots with the control numbers 0327192, 0327193, 0327194, 0327195 and 0330362 are now affected.
About 21 percent of those patches may still be in distribution, said Janssen spokeswoman Carol Goodrich. No other dosage levels are affected, the company said.
If the medication leaks from the patch, patients can get either too much or too little medication.
It's possible for a person to absorb a higher than intended amount if the medicine leaks directly onto the skin. Overexposure may cause nausea, sedation, drowsiness or potentially life-threatening complications.
If too little medication is left, it may not be enough to provide adequate pain control, and the patient may experience withdrawal symptoms.