Envolve Pharmacy Solutions: Lorazepam Oral Concentrate, USP 2mg/mL by Amneal Pharmaceuticals: Recall - Misprinted Dosing Droppers

URGENT FDA Notice - Recall

Author: Kailee Burnett/Wednesday, August 23, 2017/Categories: APCI Choice

Amneal Pharmaceuticals LLC is voluntarily recalling 13 lots of Lorazepam Oral Concentrate, USP 2mg/mL, to the Consumer level due to a defect in the dropper markings. The Lorazepam Oral Concentrate, USP 2mg/mL, product is packaged with a dosing dropper, supplied to Amneal by a third party. 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. Please immediately check your medical supplies, quarantine any drug products impacted, and not administer them. It is packaged in an individual carton, identified with the code: NDC 65162-687-84, which 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.

*Please see attached PDF for more information.

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