Amneal Pharmaceuticals, based in Bridgewater, New Jersey, has voluntarily recalled 13 lots of Lorazepam Oral Concentrate, USP 2mg/mL, Lorazepam Oral Concentrate, USP 2mg/mL — a product for which the accompanying dropper dispenser may be erroneously labeled.
“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,” officials said in a press release. The company indicated that the risk of dispensing the wrong amount warranted the recall.
Lorazepam is prescribed for anxiety disorder symptoms and/or depression. Amneal reported that no adverse reactions have been reported to date and that the dropper was supplied by a third party. The misprint came to Amneal’s attention following a consumer’s report.
Adverse reactions from improper dosage may include drowsiness; associated higher risk of accidental injury such as falling or experiencing a motor vehicle incident due to drowsiness, and/or increased anxiety.
Amneal, which manufactures generic pharmaceuticals, stated that consumers experiencing issues with product quality or adverse reactions can download forms and report details to the U.S. Food and Drug Administration at www.fda.gov/medwatch/report.htm(http://www.fda.gov/MedWatch/report.htm).
The product is packaged in a carton identified with the code: NDC 65162-687-84; contains a 30mL amber glass bottle of liquid, a package insert with patient information, and a plastic dropper sealed in plastic.