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The provided droppers may have been mislabeled.
Amneal Pharmaceuticals is voluntarily recalling 13 lots of lorazepam oral concentrate, USP 2 mg/ml. The bottles came with measuring droppers that were mismarked.
Some of the droppers were printed with markings in the reverse number order, some were blank, and in some the markings had shifted. The incorrect markings could result in a higher or lower dose of lorazepam being administered by the consumer. The droppers had been supplied to Amneal by a third party, according to a statement from the company.
Lorazepam is an anxiolytic. Too high a dose could result in potential serious adverse events including drowsiness that could cause trauma, increased anxiety, or increased accidental injury to self or others, which in the most serious circumstances could result in permanent decreased function or death. There is no safety issue with the drug, only that the mismarked droppers could cause an overdose or underdose.
The product is packaged in an individual carton, with the code: NDC 65162-687-84. Each carton contains a 30 mL amber glass bottle of liquid produced by Amneal and a plastic dropper sealed separately in a clear plastic bag. The affected Lorazepam Oral Concentrate, USP 2mg/mL, lots are:
Amneal is notifying pharmacies by sending a recall letter accompanied by a supply of replacement droppers to all pharmacies that may have received any of the recalled lots. Pharmacies are instructed to discard the dropper included with the recalled lots and replace it with one of the droppers sent with the recall letter. Amneal also is providing the pharmacist with a sticker that the pharmacist must place on the box to alert the patient and other pharmacists that the dropper has been replaced. Pharmacists should notify all consumers impacted by the recall of the potential defect and the need to exchange the defective dropper.
Amneal’s recall is being conducted with the knowledge of the FDA.
Cover photo: Examples of correctly-marked and defective droppers for Amneal Pharmaceuticals’ Lorazepam Oral Concentrate, USP 2mg/mL. Photo courtesy of Amneal Pharmaceuticals.