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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, 2838 Crenshaw Blvd, Los Angeles, CA 90016, United States

Total all time reports:  1
Latest report: April 12, 2020 12:00 PM
2 employees tested positive for COVID-19 Tests at McDonald’s, McDonald's, 2838 Crenshaw Blvd, Los Angeles, CA 90016, United States

2 employees tested positive for COVID-19 Tests at McDonald’s

April 12, 2020 12:00 PM

“Two workers from the 2838 Crenshaw location in West Adams tested positive for COVID-19.

Source: la.eater.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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“Me and my boyfriend went to there and ordered salmon off the 2 for 30 offer the salmon was cooked on the ... See Moreoutside but raw on inside the waiter immediately came and took the plate and gave us their mangers card in case we ended up at the hospital. This happened Dec 20 2019 See Less
Reported By SafelyHQ.com User

June 1, 2020 6:00 PM

“Company name: Amneal Pharmaceuticals LLC
Brand name: Amneal
Product recalled: Metformin Hydrochloride Extended-Release Tablets, USP 500mg and 750mg
Reason of the recall: Due to detection of N-Nitrosodimethylamine (NDMA)
FDA Recall date: June 01, 2020
Recall details: Amneal Pharmaceuticals L ... See MoreLC Bridgewater, New Jersey (Amneal), is voluntarily recalling all lots of Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg and 750 mg, within expiry to the Retail Level. Amneal was notified by the U.S. FDA that the Agency’s testing of seven lots of Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg and 750 mg, showed N-Nitrosodimethylamine (NDMA) amounts above acceptable FDA levels.

FDA recommended the recall of the seven tested lots. Amneal has agreed to this recall and has further decided to extend the recall to all lots within expiry of Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg and 750 mg, out of an abundance of caution. Further scientific evaluations are ongoing at Amneal. To date, Amneal has not received any reports of adverse events that have been confirmed to be directly related to this recall. Amneal’s Metformin Hydrochloride Immediate Release Tablets, USP are not affected by this recall.

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. Metformin HCl Extended-Release Tablets, USP, 500 mg and 750 mg, manufactured by Amneal, are prescription, solid oral products that are indicated as an adjunct to diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus. The Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg and 750 mg, subject to the recall, are identified by the NDC numbers stated on the product label.

Metformin HCl Extended-Release Tablets, USP, 500 mg
53746-178-01. 100 count bottles
53746-178-05. 500 count bottles
53746-178-10. 1000 count bottles
53746-178-90. 90 count bottles
53746-178-Bulk. Bulk Box
65162-178-09. 90 count bottles
65162-178-10. 100 count bottles
65162-178-11. 1000 count bottles
65162-178-50. 500 count bottles

Metformin HCl Extended-Release Tablets, USP, 750 mg
53746-179-01. 1000 count bottles
53746-179-Bulk. Bulk Box
65162-179-10. 100 count bottles

The affected Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg and 750 mg, lots were distributed nationwide in the US directly to Wholesalers, Distributors, Retailers, and Repackagers.

Amneal is notifying its direct customers via mail (UPS Standard Overnight) by mailing a recall notification letter and is arranging for the return of all the recalled products. Anyone with an existing inventory of the product should quarantine the recalled lots immediately.

Check the full recall details on fda.gov

Source: FDA
See Less
Reported By SafelyHQ.com User

April 29, 2020 7:00 PM

“Company name: CME America
Brand name: CMEAmerica BodyGuard
Product recalled: Infusion pumps and infusion sets
Reason of the recall: pumps may not deliver fluid at the accuracy specified in the instructions for use and infusion sets may under-deliver fluids
FDA Recall date: April 29, 2020
Recall ... See Moredetails: CME America, a wholly owned subsidiary of BD (Becton, Dickinson and Company), a leading global medical technology company, today issued the following update regarding two previously announced voluntary recalls, one related to all models of CMEAmerica BodyGuard® infusion pumps (FDA Recall Number: Z-1474-2020) and the other related to one of the device's infusion sets (FDA Recall Number: Z-1442-2020). Both previously announced recalls have now been designated as Class I recalls by the U.S. Food and Drug Administration (FDA), which means the FDA believes that there is a reasonable probability that use of the recalled product(s) will cause serious adverse health consequences or death.

CME America previously notified customers affected by each recall and provided guidance on the potential impact to device performance when the affected products were used. Today, the company has issued an updated customer letter with additional guidance and to inform customers of the decision to suspend distribution of the BodyGuard® infusion pump system and to remove all existing products from the U.S. market.

The following is a summary of each individual product recall details:

CMEAmerica BodyGuard® Infusion Pump Recall

Details On Jan. 6, 2020, the company initiated a voluntary recall to notify customers of certain scenarios where pumps may not deliver fluid at the accuracy specified in the instructions for use that could result in a slower than expected delivery of medication (under-infusion), and/or faster than expected delivery of medication (over-infusion). Results indicate that pumps may have a delivery inaccuracy of up to ~13%. To date, no reports of patient injury has been received related to this previously announced voluntary recall. CME America has assessed the potential risks associated with the issues outlined in the initial voluntary recall and determined that the BodyGuard® infusion pump may continue to be used in certain situations in accordance with the Operator's Manual and the additional mitigations outlined in the updated customer letter until the pumps have been removed from the market.

To ensure customers retain access to critical medical equipment, particularly as the COVID-19 pandemic continues to evolve in the United States, CME America will implement a phased market removal and will continue to support the following activities in order to help limit clinical disruption and maintain patient focus during the COVID-19 pandemic: Use of products in the field in accordance with the Operator's Manual and the additional mitigations outlined in the updated customer letter; Product service and repair activities at CME America and Authorized Service Depots; and Supply of infusion sets and accessories to support the infusion pumps remaining in the field.

The BodyGuard® infusion pump is designed to deliver fluids or medications into a patient's body in controlled amounts. The pump administers fluids through an infusion tubing set into a patient's vein or through other cleared routes of administration. The system is intended for patients who require maintenance medications, PCA therapy, parenteral nutritional fluids, and general IV fluid therapy in hospital and home care environments. Typical applications for the BodyGuard® infusion pumps include but are not limited to chemotherapy, pain management, TPN, enteral nutrition fluids and antibiotics.

The recall and market removal affect approximately 28,400 devices, including all models of BodyGuard® infusion pumps listed below. These devices are primarily used in outpatient settings.
- BodyGuard 121
- BodyGuard 323
- BodyGuard 545*
- BodyGuard 575*
- BodyGuard 545 ColorVision
- BodyGuard 575 ColorVision
- CMExpress

*Note: These two pump models were inadvertently left out of the initial customer notification

CMEAmerica BodyGuard® Microset Infusion Set Recall

Details On Sept. 16, 2019, the company initiated a voluntary recall to notify customers that certain lots of BodyGuard® Microset infusion sets, when used with the BodyGuard® infusion pump, may under-deliver fluids up to 50% at the highest flow rates. At the time of the recall, CME America informed customers in the recall announcement to discard all remaining inventory of the infusion sets (Catalog #A120-003XYVA) and committed to reimbursing impacted customers. To date, no reports of patient injury has been received related to this previously announced voluntary recall. CME America immediately stopped shipments of the affected infusion sets. This FDA classification does not change the previous guidance provided in the company's September recall announcement to customers. Affected products include:

CMEAmerica BodyGuard® Microset, Catalog #A120-003XYVA.

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

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Plymouth, MI 48170, USA

June 3, 2020 6:46 PM

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Reported By SafelyHQ.com User