Teva Pharmaceuticals recalled 13 lots of fentanyl buccal tablets, a Type II substance, because of omitted safety updates on its medication guide, the FDA said April 28.
The agency said the main concern with the excluded safety update is it "could lead to life-threatening adverse events; although, based on a Health Hazard Assessment conducted by Teva, the likelihood of the harm occurrence is considered remote."
The opiates are sold under Teva's Mayne Pharma label, and no complaints have been reported concerning the labeling.