On August 16, 2017, Amneal Pharmaceuticals LLC recalled 13 lots of Lorazepam Oral Concentrate, USP 2mg/mL, due to a defect in the dropper markings. The Lorazepam Oral Concentrate, USP 2mg/mL, product is packaged with a dosing dropper. In a few instances, the dropper was printed with the dose markings in reverse number order, had no dose markings, or had dose markings that were shifted.
Lorazepam Oral Concentrate, USP 2mg/mL, is indicated for the management of anxiety disorders for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms.
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). In the most serious circumstances, an adverse event could result in permanently decreased function or death.
Lorazepam Oral Concentrate, USP 2mg/mL, is packaged in an individual carton, identified with the code NDC 65162-687-84. An individual carton contains a 30mL amber glass bottle of liquid produced by Amneal, a package insert with patient information, and a plastic dropper sealed in a clear plastic bag. The Lorazepam Oral Concentrate, USP 2mg/mL was distributed nationwide to wholesalers.
See the FDA Safety Alert
See the Recall
See also Medical Law Perspectives Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication