Recall: Amneal Pharmaceuticals LLC Lorazepam Oral Concentrate, USP 2mg/mL
On 2017-08-16, the FDA announced that Amneal Pharmaceuticals is conducting a recall on Lorazepam Oral Concentrate, USP 2mg/mL due to a possible package tampering. The recalled products were sold under the brand name(s) Amneal Pharmaceuticals LLC during an unspecified time period throughout the regions shown in the map below.
In recent months, there have been 2 drugs recalls due to potential package tampering, including mibelas 24 fe (norethindrone acetate and ethinyl estradiol 1 mg/0.02 mg chewable and ferrous fumarate 75 mg), weight loss product and more. Additionally, there have been 23 drug and medical device recalls due to other health hazards as well as 121 food recalls.
Company Contact Information:
Name: Amneal Pharmaceuticals
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Detailed Recall Information
Regions Where Sold: Because the region was not specified, it is assumed that this product was available nationwide.
Product Description: Lorazepam Oral Concentrate, USP 2mg/mL
Brand Name(s): Amneal Pharmaceuticals LLC
Reason for Recall: Misprinted Dosing Droppers
Official Recall Date: 2017-08-14
Note: Although this recall announcement is dated 08/14/2017, it was not published by the FDA until 08/16/2017.
Additional information provided by the FDA.gov:
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. Amneal learned about the issue from a Consumer's report. To date no adverse events related to these dropper defects have been reported to Amneal. The below picture shows examples of a dropper with the correct print, along with examples of droppers with the defects. Read More.
More information may be available at FDA.gov
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Sources may include Food & Drug Administration (FDA), United States Department of Agriculture (USDA), Health Canada and companies involved with this or a related recall.