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Recall: Lorazepam Oral Concentrate recalled by Amneal Pharmaceuticals

Defects in dropper markings have led Amneal Pharmaceuticals to announce a voluntary recall of 13 lots of Lorazepam Oral Concentrate USP 2mg/ml. A consumer report drew the generic drug manufacturer's attention to the issue with the dosing dropper, which is supplied to Amneal by a third party. Some markings on the dosing tools are printed in reverse number order, have shifted, or have no markings at all. At the time of writing, no adverse events related to the defective droppers were reported to Amneal. 

Lorazepam is indicated for managing anxiety disorders, the short-term relief of symptoms of anxiety, and anxiety symptoms associated with depressive symptoms. It is contraindicated in patients with hypersensitivity to benzodiazepines or any components of the formulation, and patients with acute narrow-angle glaucoma. The most frequent side effects of the drug among patients treated for anxiety are sedation, dizziness, weakness, and unsteadiness.

Amneal Pharmaceuticals is a generic drug manufacturer based in Bridgewater, New Jersey. This year it released a number of new generic products onto the market, including the first US Food and Drug Administration (FDA) approved 100mg Thiothepa, approved to reduce the risk of graft rejection, and a new generic for Zetia (ezetimibe).

Why the recall?

Incorrect dropper markings could result in patients dispensing too much or too little of the medicine, according to the FDA risk report. The regulatory body warned there is a "significant probability of a serious health consequence" if patients take more than the prescribed dose. Potential adverse events include drowsiness causing trauma; increased anxiety; and increased accidental injury, for example, a hip fracture or motor vehicle accident, which in the most serious cases could lead to permanent decreased function or even death. 

Is my product affected?

A total of 13 lots were recalled, with the numbers listed below. The product contains a 30ml amber glass bottle of liquid and comes in an individual carton, marked with the code NDC 65162-687-84. Patients can check their medication by looking at the lot number printed "on the bottom-right side of the blue and white label, with the Amneal logo, on the amber bottle supplied with the dropper, in a blue and white carton, with the Amneal logo".

06876016A 08/2018

06876017A 08/2018

06876018A 08/2018

06876019A 09/2018

06876020A 09/2018

06876021A 09/2018

06876022A 09/2018

06876023A 11/2018

06876024A 12/2018

06876025A 12/2018

06877001A 02/2019

06877002A 02/2019

06877003A 03/201z

What to do if you have an affected product

Amneal Pharmaceuticals issued a recall letter to wholesale customers and has also sent recall letters out alerting pharmacies to the issue. Consumers are advised to cease using any defective droppers and to return to the place of purchase for a new one. Replacement droppers have been supplied to all pharmacies that may have received affected lots of lorazepam oral concentrate. Pharmacies have also been supplied with stickers to put on the boxes to alert consumers and other pharmacists that replacement droppers are now in use. 

Where to find more information

Patients concerned about the quality of their dropper and whether they are affected by the recall have been encouraged to confer with their dispensary for clarification. Other questions regarding the recall can be addressed to Amneal Pharmaceuticals at 631-952-0214 x338 or, Monday through Friday from 09:00 to 17:00 EST.

Adverse reactions or other quality problems can be reported to the FDA MedWatch Adverse Event Reporting program.