Recall: Hospira 0.25% Bupivacaine HCl Injection & 0.75% Bupivacaine HCl Injection
On 2013-09-13, the FDA announced that Hospira is conducting a recall on 0.25% Bupivacaine HCl Injection & 0.75% Bupivacaine HCl Injection due to possible contamination with foreign matter. The recalled products were sold under the brand name(s) Hospira during an unspecified time period throughout the regions shown in the map below.
In recent months, there have been 6 drugs recalls due to potential contamination, including infants' drops, 10 percent, sulfite-free, 500ml and more. Additionally, there have been 30 drug and medical device recalls due to other health hazards as well as 62 food recalls.
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Detailed Recall Information
Regions Where Sold: Nationwide
Product Description: Bupivacaine HCl Injections
Brand Name(s): Hospira
Reason for Recall: Particulates - Stainless Steel & Iron Oxide
Official Recall Date: 2013-09-13
Additional information provided by the FDA.gov:
Hospira, Inc. (NYSE: HSP), announced today, on July 12, 2013, it initiated a voluntary nationwide recall to the user level for one lot of 0.25% Bupivacaine HCl Injection, USP (2.5 mg/mL), 30 mL Single-dose Vial (NDC 0409-1159-02). An expanded recall was issued on August 29, 2013 for one lot of 0.75% Bupivacaine HCl Injection, USP (7.5 mg/mL), 30 mL Single-dose Vial (NDC 0409-1165-02). Both recalls are due to confirmed customer reports of particulate floating and/or embedded in the glass vial. The particulate was identified as stainless steel ranging in size from 542 microns to 1700 microns in lot 18-136-DK (0.25% bupivacaine) and as iron oxide with an average size of 2000 microns in lot 23-338-DK (0.75% bupivacaine). To date, Hospira has not received reports of any adverse events associated with this issue for this lot. 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.