Recall: Hospira, Novaplus Labetalol Hydrochloride Injection, USP
On 2018-02-23, the FDA announced that Hospira is conducting a recall on Labetalol Hydrochloride Injection, USP due to a possible lack of sterility. The recalled products were sold under the brand name(s) Hospira and Novaplus during an unspecified time period throughout the regions shown in the map below.
In recent months, there have been 4 drugs recalls due to potential lack of sterility, including sterile eye irrigation solution, various compounded drug products intended to be sterile and more. Additionally, there have been 17 drug and medical device recalls due to other health hazards as well as 73 food recalls.
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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: Labetalol Hydrochloride Injection, USP
Brand Name(s): Hospira, Novaplus
Reason for Recall: Lack of Sterility
Official Recall Date: 2018-02-23
Additional information provided by the FDA.gov:
Hospira, Inc., a Pfizer company, is voluntarily recalling 3 lots of Labetalol Hydrochloride Injection, USP, 100 mg/20 mL Vial (NDC 0409-2267-20), and one lot of Labetalol Hydrochloride Injection, USP, Novaplus (NDC 0409-2267-25) to the hospital/institution level. Hospira, Inc. initiated this recall due to the discovery of cracks on the rim surface of vials for these lots, which is covered by the stopper and crimp seal. 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.