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IMPORTANT - YOUR REPORT IS QUEUED - IT MAY TAKE UP TO 12 HOURS FOR YOUR REPORT TO SHOW ON OUR HOME PAGE (IF NOT OPTED AS PRIVATE)

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McDonald's, 2100 Lathrop Ave, Racine, WI 53405, USA

Total all time reports:  1
Latest report: May 5, 2020 12:00 PM
A restaurants employee has tested positive for COVID-19, McDonald's, 2100 Lathrop Ave, Racine, WI 53405, USA

A restaurants employee has tested positive for COVID-19

May 5, 2020 12:00 PM

“A McDonald's employee has tested positive for COVID-19 on Sat. If you visited the recently, please report it and any other location that you visited.

Source: racinecountyeye.com See Less
Reported By SafelyHQ.com User

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“Company name: CME America
Brand name: BodyGuard
Product recalled: Infusion System Administration Set (infusion set)
Reason of the recall: Use of the pump system potentially could cause over-infusion or under-infusion of therapy
FDA Recall date: July 08, 2020
Recall details: PRNewswire/ - CME Am ... See Moreerica, a wholly owned subsidiary of BD (Becton, Dickinson and Company), announced a voluntary recall for all CME America BodyGuard® Infusion System Administration Sets (infusion sets) used with the company's BodyGuard® infusion pumps—that were distributed beginning May 2016 (see complete impacted product list below).  This action was initiated on June 16, 2020. As part of CME America's commitment to quality, following the previously announced recall (April 27, 2020) of the BodyGuard® Infusion Pump Systems, the company conducted additional flow-rate accuracy testing.

This testing revealed that some infusion sets do not meet the ±5% delivery accuracy for the system or the ±13% accuracy identified in the earlier recall notification (bd.com Therefore, the use of the pump system potentially could cause over-infusion or under-infusion of therapy and patient harm. Based on those test results CME America is providing additional information and customer actions regarding its previous recall to include all infusion sets used with the BodyGuard® infusion pump distributed beginning May 2016.

CME America has defined four categories of impacted infusion sets based on delivery inaccuracy variability, two of which (Category A and B) can continue to be used in accordance with the instructions in the recall letter (bd.com CME America also announced on April 27, 2020, the decision to suspend distribution of the BodyGuard® infusion pumps and to remove all existing products from the U.S. market. CME America will work with customers to address the latest expanded infusion set recall and will continue to maintain continuity of care during the COVID-19 pandemic. Until such time that the BodyGuard® pumps have been removed from the market, CMEA will supply accessories and infusion sets in "Category A" and "Category B" to support the infusion pumps, and customers can continue to use the products in accordance with the Operator's Manual and the additional mitigations outlined in the customer letter.

Affected Product Types:

- BodyGuard BodySet
- BodyGuard Microset with Needleless Adaptor
- BodyGuard Microsets
- BodyGuard Microset w/ Non-Vented Spike Connector
- BodyGuard set with Female Luer
- BodyGuard Microset w/ 0.2 mic filter and lower y-site with female luer
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- Standard BodySet with Needleless Connectors
- BodyGuard Microset with Filter and Manual Priming Valve
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- CMExpress Needleless Y Site Microbore Set

Check the full recall details on fda.gov

Source: FDA
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“Company name: Braun Medical Inc
Brand name: B. Braun
Product recalled: Ceftazidime for Injection USP (2g) and Dextrose for Injection USP (50 ml) in Duplex® Container
Reason of the recall: Out-of-Specification Results for High Molecular Weight Polymers
FDA Recall date: April 20, 2020
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:

- NDC: 0264-3145-11. Ref: 3145-11. Dose/Volume: 2 g per 50 mL. Impacted batch: H8J812. Exp. Date: 31 Jul 2020.

Product was distributed Nationwide within the United States to domestic distributors. Pictures of the product and product labeling follow this press release.

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

Check the full recall details on fda.gov

Source: FDA
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“Company name: Becca Cosmetics
Brand name: Becca Cosmetics
Product recalled: Light Shifter Brightening Concealer
Reason of the recall: Potential Mold
FDA Recall date: May 07, 2020
Recall details: Company Announcement Out of abundance of caution, and in line with its commitment to consumer sat ... See Moreisfaction and safety, Becca Cosmetics is voluntarily recalling all shades of its Light Shifter Brightening Concealer because a brownish-black material identified as a common household mold was found on the sponge-tip applicator of some units. While this is unlikely to cause serious injury there is a potential risk of temporary skin and/or eye allergy and irritation.

To date, no adverse reactions or injuries have been reported. This product was manufactured in the United States and distributed nationwide. The below are the details of the product affected by this recall. No other Becca Cosmetics products are affected by this issue.

- Product Name: Becca Cosmetics Light Shifter Brightening Concealer
- Batch: 0030A, 9308A, 0052A, 0052C, 9291A, 9309A, 0036A, 0037A, 0038A, 0038B, 0041A, 9289A, 0062A, 0062B, 0062C, 9283A, 9284A, 9287A, 9288A
- Size: 3.2 mL (only size available)
- Product Description: Concealer wand with silver overlay, and a white secondary carton
- UPC: 9331137030037, 9331137030044, 9331137030051, 9331137030068, 9331137030075, 9331137030099, 9331137030082, 9331137030105

If you have this product, please stop using it and contact the place of purchase regarding a refund. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Check the full recall details on fda.gov

Source: FDA
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“Company name: Avet Pharmaceuticals Labs Inc.
Brand name: Heritage
Product recalled: Tetracycline HCl Capsules, 250mg and 500mg
Reason of the recall: Due to low out of specification dissolution results
FDA Recall date: April 16, 2020
Recall details: Avet Pharmaceuticals Inc. (“Avet”), based in ... See MoreEast Brunswick, New Jersey, is initiating a voluntary recall of the following lots of Tetracycline HCl Capsules USP, 250 mg and 500 mg, 100-count bottles listed in the table below to the consumer/user level.

- Tetracycline HCl Capsules 250 mg 100 count. NDC number: 23155-017-01. Lot No: H190666. Expiry Date: JUL 2022
- Tetracycline HCl Capsules 500 mg 100 count. NDC number: 23155-018-01. Lot No: G190609. Expiry Date: JUN 2022
- Tetracycline HCl Capsules 500 mg 100 count. NDC number: 23155-018-01. Lot No: G190610. Expiry Date: JUN 2022
- Tetracycline HCl Capsules 500 mg 100 count. NDC number: 23155-018-01. Lot No: G190611. Expiry Date: JUN 2022
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- Tetracycline HCl Capsules 500 mg 100 count. NDC number: 23155-018-01. Lot No: K190953. Expiry Date: OCT 2022
- Tetracycline HCl Capsules 500 mg 100 count. NDC number: 23155-018-01. Lot No: K190952. Expiry Date: OCT 2022

These drug products are manufactured by Avet Pharmaceuticals Labs Inc. and distributed under the Heritage Pharmaceuticals Inc. label. The voluntary recall is being initiated due to low out of specification dissolution test results.

Low dissolution results in less tetracycline available in the body to fight infection. This can lead to treatment failures. For patients with compromised immune systems and the elderly, who may be taking tetracycline to treat a serious infection such as pneumonia, there is a reasonable probability that if there is not enough tetracycline in the body to fight the infection, this could result in rapid progression of the infection and death. To date, Avet has not received adverse event reports or complaints related to this event.

The recalled Tetracycline HCl Capsules 250 mg and 500 mg lots were distributed to wholesalers and distributors Nationwide in United States between August 2019 and March 2020.

Avet is notifying its distributors and customers by a separate notification to distributors and through Qualanex and is arranging for the return of all recalled products. Consumers should contact their doctor for further guidance and potential change of treatment before they stop taking this drug product. Pharmacies and healthcare facilities that have the drug product subject to this recall should immediately stop dispensing this drug product.

Check the full recall details on fda.gov

Source: FDA
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what can be done about this? See Less
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