Medication Monitor

Generic Name (Trade Name—Company)
August 16, 2017

Lorazepam oral concentrate

(No trade name—Amneal Pharmaceuticals)
Misprinted dosing droppers supplied with 13 lots of lorazepam oral concentrate

Amneal Pharmaceuticals is voluntarily recalling 13 lots of lorazepam oral concentrate, USP 2 mg/mL, to the consumer level due to a defect in the dropper markings. In a few instances, the dosing dropper, supplied to Amneal by a third party, is printed with the dose markings in reverse number order, has no dose markings, or has dose markings that are shifted.

There is a significant likelihood that the dropper marking errors will result in dispensing either less than, or more than, the prescribed dose. There is a significant probability of a serious health consequence if more than the prescribed dose is dispensed. Potential serious adverse events include drowsiness, causing trauma; increased anxiety; and 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.

The product is indicated for short-term relief of symptoms of anxiety or anxiety associated with depressive symptoms. It is packaged in an individual carton, identified with the code NDC 65162-687-84, which contains a 30-mL amber glass bottle of liquid produced by Amneal; a package insert with patient information; and a plastic dropper sealed in a clear plastic bag. A list of the affected lots can be found here.

The product was distributed nationwide to wholesalers.

To date, no adverse events related to these dropper defects have been reported to Amneal.