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Wendy's, 6892 Garners Ferry Rd, Columbia, SC 29209, United States
Total all time reports:
1
Latest report: June 25, 2020 5:31 PM
More incidents from:
Restaurant
Wendy's
6892, Garners Ferry Road
Columbia
South Carolina
United States
Wendy's, 6892 Garners Ferry Rd, Columbia, SC 29209, United States
June 25, 2020 5:31 PM
“serving raw chicken See Less ”
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Recall de ... See Moretails: Braun Medical Inc. (B. Braun) is voluntarily recalling one (1) lot of 2g Ceftazidime for Injection USP (2g) and Dextrose for Injection USP (50 ml) in Duplex® Container to the hospital/user level.. During stability testing of Batch H8J812, test results were found to exceed the specification limits for High Molecular Weight Polymers (HMWP) at the nineteen (19) month [82 week] stability interval. Elevated levels of High Molecular Weight Polymers have been shown to cause kidney damage and liver issues in animal studies. While the impact of HMWP in humans is unknown, B. Braun is initiating this voluntary recall out of an abundance of caution to prevent any risks of adverse reactions due to the elevated HMWP levels.
To date there have been no complaints or reports of adverse reactions associated with this product lot. Ceftazidime for Injection USP and Dextrose Injection USP is a cephalosporin antibacterial indicated in the treatment of the following infections caused by susceptible isolates of the designated microorganisms: Lower respiratory tract infections; skin and skin-structure infections; bacterial septicemia; bone and joint infections; gynecologic infections; intra-abdominal infections; and central nervous system infections.
Ceftazidime for Injection USP and Dextrose Injection USP in the DUPLEX® Container is a flexible dual chamber container containing approximately 50 mL of 5% Dextrose Injection in the diluent chamber and ceftazidime in the drug powder chamber. After reconstitution, the concentration is equivalent to 2 g ceftazidime. Ceftazidime for Injection USP and Dextrose Injection USP is packaged in 24 DUPLEX® Containers per case. The affected recalled product includes the following lot number and expiration date:
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B. Braun is notifying its distributors and customers by an official recall notice sent via certified registered mail and is arranging for return of all recalled products. Facilities and distributors that have product which is being recalled should discontinue use immediately and contact the B. Braun Medical Inc. Customer Support Department
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Saniderm is notifying its distributors and customers by email and is arranging for the handling of all voluntary recalled products. All individuals that have the bottle in question should immediately stop using and contact Saniderm for guidance on the return and disposal of the product. Consumers with questions regarding this voluntary recall can contact Saniderm at +1 (415) 562-5502 or info@sanidermproducts.com from Monday-Friday 9am-6pm, PST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this drug product. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Complete and submit the report Online
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