Amneal recalls lorazepam oral concentrate

Privately-held USA-headquartered generics manufacturer Amneal Pharmaceuticals is voluntarily recalling 13 lots of lorazepam oral concentrate, USP 2mg/mL, to the consumer level due to a defect in the dropper markings, the US Food and Drug Administration announced today.

The lorazepam oral concentrate product is packaged with a dosing dropper, supplied to Amneal by a third party. In a few instances, the dropper is printed with the dose markings in reverse number order, has no dose markings or has dose markings that are shifted. Amneal learned about the issue from a Consumer's report. To date no adverse events related to these dropper defects have been reported to Amneal.

There is a significant likelihood that the dropper marking errors will result in dispensing either less than, or more than, the prescribed dose, the FDA pointed out. 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 (eg, hip fracture, motor vehicle accident); which in the most serious circumstances could result in permanent decreased function or death.