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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, 74-5453 Makala Blvd, Kailua-Kona, HI 96740, United States

Total all time reports:  2
Latest report: April 16, 2020 12:00 PM
Seven fast food restaurant employees contracted Coronavirus, McDonald's, 74-5453 Makala Blvd, Kailua-Kona, HI 96740, United States

Seven fast food restaurant employees contracted Coronavirus

April 16, 2020 12:00 PM

“An employee who contracted the coronavirus inadvertently infected six other workers at McDonald’s locations on Makala Boulevard at Kona Commons and Walmart in Kailua-Kona, which has since closed operations.

In addition, five family members exposed to two of the COVID-positive employees have contr ... See Moreacted the virus, bringing the total number of connected cases to 12.

Source: staradvertiser.com
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Reported By SafelyHQ.com User

8 people sick with COVID-19 connected to the restaurant

April 15, 2020 12:00 PM

“A McDonald's employee tested positive for COVID-19 on Thursday April 9. Contact tracing resulted in an additional 8 coworkers and family members testing positive for coronavirus.

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

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“Company name: IcelandicPlus LLC
Brand name: Icelandic+
Product recalled: Whole Capelin Fish Pet Treats
Reason of the recall: Potential for Clostridium botulinum
FDA Recall date: March 23, 2020
Recall d ... See Moreetails: Out of an abundance of caution IcelandicPlus LLC of Ft. Washington, PA, is recalling its Capelin Pet Treats because some of the fish have exceeded the FDA compliance guideline for fish larger than 5 inches. The FDA has determined that salt-cured, dried, or fermented un-eviscerated fish larger than 5 inches have been linked to outbreaks of botulism poisoning in humans between 1981 and 1987 and again in 1991. Since some IcelandicPlus Capelins are larger than 5 inches there is a possible health risk. To date there have been no reported illnesses of dogs, cats, or persons in connection with Capelin. Nor has there been any positive test results for Clostridium botulinum from any IcelandicPlus Capelin, but because of the potential risk, and despite no known illnesses in connection with our products, we have decided in co-operation with the FDA, to announce this product recall. Clostridium botulinum toxin can cause severe clinical signs including death in both animals consuming the pet treat and people handling the pet treat or coming in contact with contact areas that have been exposed to the product. Common symptoms may include dizziness, blurred or double vision, trouble with speaking or swallowing, difficulty breathing, muscle weakness, abdominal distension, and constipation. Consider that several of the listed symptoms, such as double vision, cannot be easily assessed in animals or conveyed by an animal. Pets or persons experiencing these symptoms should seek immediate medical attention. The Capelin product was shipped to distributors in the United States with the intent to be sold to Retailers who in turn sell to Consumers. This product would be found in Independent Pet Specialty Stores within all States in the United States. The product comes in a clear plastic package or tube, and marked Icelandic+ Capelin WHOLE FISH, PURE FISH TREATS FOR DOGS, or PURE FISH TREATS FOR CATS UPC CODES, 8 5485400775 9; 8 5485400711 7; and 8 5485400757 5 are packaged in a 2.5 ounce tube or a 1.5 or 2.5 ounce bag (lot numbers 02/2020 to 02/2022)IcelandicPlus is family owned and run by pet parents who take the safety and wellbeing of its consumers and clients with the utmost importance, as such we are conducting this voluntarily recall to further protect our customers. Additionally, we are changing our Capelin supplier to ensure that the fish in our product are consistently less than 5 inches, or if larger, they will be completely eviscerated. Distributors, Retailers and Consumers who have purchased IcelandicPlus’s Capelin can return it to the location where it was purchased for a refund.
Check the full recall details on fda.gov
Source: FDA
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Reported By SafelyHQ.com User

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“Company name: Marksans Pharma Limited, India
Brand name: Time-Cap Labs, Inc.
Product recalled: Metformin Hydrochloride Extended-Release Tablets, USP 500mg
Reason of the recall: Due to detection of N-Nitrosodimethylamine (NDMA)
FDA Recall date: June 05, 2020
Recall details: Marksans Pharma Limi ... See Moreted, India is voluntarily recalling Metformin Hydrochloride Extended-Release Tablets, USP 500mg, lot # XP9004, to the consumer level. FDA analysis has found the product to contain N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit (ADI) of 96ng/day. Risk Statement: NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant found in water and foods, including meats, dairy products and vegetables.

Marksans Pharma Limited has not received any reports of adverse events related to this recall to date. Metformin Hydrochloride Extended-Release Tablets, USP 500mg is indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus and is packaged in 100 count bottles with NDC code 49483-623-01. The affected Metformin Hydrochloride Extended-Release Tablets, USP 500mg, are white to off white, capsule shaped, biconvex tablets, debossed with ‘101’ on one side and plain on the other side.

Product name: Metformin Hydrochloride Extended Release Tablets USP, 500 mg
Lot #: XP9004
Expiry Date (MM/YYYY): 12/2020

The product can be identified by lot # XP9004 and expiration date 12/2020. Metformin Hydrochloride Extended-Release Tablets, USP 500mg, lot # XP9004 was distributed by Time-Cap Labs, Inc. nationwide in the USA to wholesalers who further distributed to pharmacies. Marksans Pharma Limited is notifying its distributors and customers by issuing notification letter and press release and is arranging for return/replacement etc. of recalled product lot.

Distributors/retailers that have Metformin Hydrochloride Extended-Release Tablets, USP 500mg, lot # XP9004 which is being recalled should return to place of purchase. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or 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

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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Reported By SafelyHQ.com User

April 16, 2020 3:00 PM

“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
- Tetracycline HCl Capsules 500 mg 100 count. NDC number: 23155-018-01. Lot No: L191027. Expiry Date: NOV 2022
- Tetracycline HCl Capsules 500 mg 100 count. NDC number: 23155-018-01. Lot No: L191028. Expiry Date: NOV 2022
- 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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Reported By SafelyHQ.com User