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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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Publix Super Market at Midway Plaza, 5881 N University Dr, Tamarac, FL 33321, USA

Total all time reports:  1
Latest report: April 26, 2020 12:00 PM
Supermarket employee Tests Positive for COVID-19, Publix Super Market at Midway Plaza, 5881 N University Dr, Tamarac, FL 33321, USA

Supermarket employee Tests Positive for COVID-19

April 26, 2020 12:00 PM

“The Publix supermarket at Midway Plaza on North University Drive in Tamarac has confirmed positive coronavirus cases.

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

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“Company name: Teva Pharmaceuticals USA Inc.
Brand name: Actavis
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 05, 2020
Recall details: Teva Pharmaceuticals U ... See MoreSA, Inc. is voluntarily recalling fourteen (14) lots of Metformin Hydrochloride Extended-Release Tablets, USP 500 mg and 750 mg, 100 and 1000 count bottles, in the United States to the consumer-level due to the detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit (ADI). 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 and found in water and foods, including meats, dairy products, and vegetables. Metformin Hydrochloride is indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus.

The lots being recalled are packaged under the Actavis Pharma, Inc. label and are contained in the table below. They were distributed nationwide in the USA as retail bottles of 100 tablets and 1000 tablets to Teva’s direct customers between January 8, 2019 and May 27, 2020. The affected Metformin Hydrochloride Extended-Release Tablets, USP 500 mg and 750 mg, being recalled are described as:

- Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, white to off-white capsule shaped tablets, debossed with an Andrx logo with “571”on one side and “500” on the opposite side.

- Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, light yellow capsule shaped tablets, debossed with an Andrx logo with “577” on one side and “750” on the opposite side.

- NDC: 62037-571-01/ Product Description Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 100 Count/ Lot Number: 1329548A/ Expiration: 06/2020

- NDC: 62037-571-01/ Product Description: Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 100 Count/ Lot Number: 1338302M/ Expiration: 10/2020

- NDC: 62037-571-01/ Product Description: Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 100 Count/ Lot Number: 1348968M/ Expiration: 10/2020

- NDC: 62037-571-01/ Product Description: Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 100 Count/ Lot Number: 1348969M/ Expiration: 11/2020

- NDC: 62037-571-01/ Product Description: Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 100 Count/ Lot Number: 1348970M/ Expiration: 10/2020

- NDC: 62037-571-01/ Product Description: Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 100 Count/ Lot Number: 1376339M/ Expiration: 09/2021

- NDC: 62037-571-10/ Product Description: Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 1000 Count/ Lot Number: 1323460M/ Expiration: 06/2020

- NDC: 62037-571-10/ Product Description: Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 1000 Count/ Lot Number: 1330919M/ Expiration: 06/2020

- NDC: 62037-571-10/ Product Description: Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 1000 Count/ Lot Number: 1338300A/ Expiration: 10/2020

- NDC: 62037-571-10/ Product Description: Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 1000 Count/ Lot Number: 1341135M/ Expiration: 12/2020

- NDC: 62037-571-10/ Product Description: Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 1000 Count/ Lot Number: 1391828M/ Expiration: 11/2021

- NDC: 62037-577-01/ Product Description: Metformin Hydrochloride Extended-Release Tablets, USP 750 mg 100 Count/ Lot Number: 1333338M/ Expiration: 08/2020

- NDC: 62037-577-01/ Product Description: Metformin Hydrochloride Extended-Release Tablets, USP 750 mg 100 Count/ Lot Number: 1333339A/ Expiration: 08/2020

- NDC: 62037-577-10/ Product Description: Metformin Hydrochloride Extended-Release Tablets, USP 750 mg 1000 Count/ Lot Number: 1354471A/ Expiration: 02/2021

Teva is notifying its distributors and customers affected by this recall via FedEx overnight mailing. Patients taking Metformin Hydrochloride Extended-Release Tablets, USP 500 mg and 750 mg, are advised to continue taking their medication and contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment. According to the US Food & Drug Administration, It could be dangerous for patients with this serious condition to stop taking their metformin without first talking to their health care professionals.

Check the full recall details on fda.gov

Source: FDA
See Less
Reported By SafelyHQ.com User

May 12, 2020 9:35 PM

“The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced the recall of approximately 3,302 pounds of meat and poultry flatbread ... See More/product/pizza#scroll" title="Product: Pizza">pizza products by Ideal Foods that were produced, packed, and distributed without the benefit of federal inspection. There have been no confirmed reports of adverse reactions related to this recall to date.

The recalled products were produced on various dates from October 2019 to April 2020 and bear establishment number “EST. 45351A” or “P-45351A” inside the USDA mark of inspection. These items were shipped to a distributor and retail locations in California.

- 13.5-oz. plastic-wrapped cardboard trays containing “culinevo Artisan Style Flatbread Pizza CARNE ASADA”.
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Check the full recall details on the FSIS website fsis.usda.gov

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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 4, 2020 11:43 PM

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Symptoms: Other
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June 5, 2020 4:09 AM

“I had tinned tuna around 8:15pm on 4th June. I noticed the tuna appeared strange after a few normal mouthfuls. T ... See Morehe next mouthful I had my mouth was immediately stinging and it tasted slightly metallic. This put me off and I stopped eating, however, my dog had also had a small amount in her dinner. Quite soon after my stomach felt unsettled. About 30 minutes later I had heart palpitations which lasted a short while. About an hour after eating I had itchy hive like bumps appear on my stomach and lower back. My stomach and chest appeared flushed and hot. The hive bumps persisted for a few hours but I had no further symptoms. My dogs stomach also appeared unsettled soon after she ate, as her peristalsis was audible. About 3 hours after she ate the tuna she was sick and appeared quite lethargic. About 6 hours later she felt very hot to the touch and was scratching. 12 hours later she was back to normal. See Less
Reported By SafelyHQ.com User

May 26, 2020 9:34 PM

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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
See Less
Reported By SafelyHQ.com User