Amneal Pharmaceuticals said today that it is voluntarily recalling 13 lots of its oral lorazepam product due to a defect in the dosing dropper.
In some cases, the dropper is printed with the dose markings in reverse order or has no dose markings at all, according to the Bridgewater, N.J.-based company. So far, no adverse events related to the dropper defect have been reported.
“There is a significant likelihood that the dropper marking errors will result in dispensing either less than, or more than, the prescribed dose,” the company wrote in prepared remarks. “There is a significant probability of a serious health consequence if more than the prescribed dose is dispensed and potential serious adverse events include – drowsiness causing trauma; increased anxiety; increased accidental injury to self or others (e.g., hip fracture, motor vehicle accident); which in the most serious circumstances could result in permanent decreased function or death.”
Affected product lots include 06876016A, 06876017A, 06876018A, 06876019A, 06876020A, 06876021A, 06876022A, 06876023A, 06876024A, 06876025A, 06877001A, 06877002A, and 06877003A.
Amneal’s lorazepam product is indicated for the management of anxiety disorders and the short-term relief of the symptoms of anxiety.