Amneal Pharmaceuticals Recalls Lorazepam Oral Concentrate

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The company is voluntarily recalling Lorazepam Oral Concentrate, USP 2mg/mL because of misprinted dosing droppers.

On August 14, 2017, Amneal Pharmaceuticals (Bridgewater, NJ) announced it was recalling 13 lots of Lorazepam Oral Concentrate, USP 2mg/mL to the consumer level because of incorrect markings on the lots’ droppers. The recall was issued after the defect was reported by a customer.

Amneal packages Lorazepam Oral Concentrate, USP 2mg/mL with a dosing dropper supplied by a third party. The affected lots had droppers that either had dose markings in reverse order, no dose markings, or shifted dose markings. While no adverse events have yet to be reported regarding the recalled lots, the company stated in a press release that the errors in the dosing marks could result in dispensing either less than or more than the prescribed dose. Incorrect dosage may cause serious effects including drowsiness, anxiety, or accidental injury.

Lorazepam Oral Concentrate, USP 2mg/mL, which is used for the management of anxiety disorders, is packaged in an individual carton that contains a 30mL amber glass bottle of liquid, a patient information insert, and a plastic dropper sealed in a clear plastic bag. The recalled lots have expiration dates ranging from August 2018 to March 2019 and were distributed nationwide to wholesalers. The company has notified its customers to return all lots. Pharmacies are being instructed to discard the dropper included in the recalled lots and replace it with a new dropper included with a recall letter.      


Source: FDA