Amneal Recalls Lots of Anxiety Drug Lorazepam

Amneal Pharmaceuticals, a Paterson, New Jersey-based generic-drug manufacturer, has voluntarily recalled 13 lots of its anxiety medication, lorazepam oral concentrate USP 2mg/mL, due to a defect in the dropper’s markings.

The 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, according to the the company. The product was distributed nationwide to wholesalers.

In it is recall notice, the company explains that there is a significant likelihood that the dropper-marking errors will result in dispensing either less than, or more than, the prescribed dose. In addition, there is 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; increased accidental injury to self or others (e.g., hip fracture, motor vehicle accident), in which in the most serious circumstances could result in permanent decreased function or death.

Amneal Pharmaceuticals has notified its wholesale customers by a recall letter to return all recalled lots. Amneal is notifying pharmacies by providing a recall letter and a supply of replacement droppers to all pharmacies that may have received any of the recalled lots.

There is no safety issue with the bottled product itself, according to the company. To avoid any interruption in supply or access to the medication by the patient, pharmacies are instructed to immediately discard the dropper included with the recalled lots and replace it with the dropper included with the recall letter.

Source: Amneal Pharmaceuticals and US Food and Drug Administration

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