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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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Merriman's Maui, Bay Club Pl, Lahaina, HI 96761, United States

Total all time reports:  1
Latest report: April 23, 2020 12:00 PM
Three workers tested positive for the coronavirus, Merriman's Maui, Bay Club Pl, Lahaina, HI 96761, United States

Three workers tested positive for the coronavirus

April 23, 2020 12:00 PM

“Three workers at Merriman’s Maui have tested positive for COVID-19. About 65 people were potentially exposed to the virus.

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

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“Company name: Lupin Pharmaceuticals, Inc.
Brand name: Lupin
Product recalled: Metformin Hydrochloride Extended-Release Tablets, 500mg and 1000mg
Reason of the recall: N-Nitrosodimethylamine (NDMA) Impurity
FDA Recall date: July 08, 2020
Recall details: Lupin Pharmaceuticals Inc. is voluntarily ... See Morerecalling all batches of Metformin Hydrochloride Extended-Release Tablets USP, 500mg and 1000mg to the consumer level. As part of the ongoing assessment and continuation of the dialog with the FDA, additional analysis revealed that certain tested batches were above the Acceptable Daily Intake Limit for the impurity N-Nitrosodimethylamine (NDMA). Out of an abundance of caution, the company is recalling all batches of Metformin Hydrochloride Extended-Release Tablets USP, 500mg and 1000mg in the US. To date, Lupin Pharmaceuticals Inc. has not received any reports of adverse events related to 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 and found in water and foods, including meats, dairy products and vegetables.

Metformin Hydrochloride Extended-Release Tablets USP is a prescription oral medication indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus. Metformin Hydrochloride Extended-Release Tablets USP, 500mg and 1000mg is packaged in 60, 90 and 100 count bottles and was distributed nationwide in the US to wholesalers, distributors, drug chain, mail order pharmacies and supermarkets. The recalled NDC’s are included in the table below:

- Product: Metformin Hydrochloride Extended-Release Tablets USP/ Strength: 500mg/ NDC: 68180-338-01 / Distribution Dates: 11/21/2018 - 05/27/2020

- Product: Metformin Hydrochloride Extended-Release Tablets USP/ Strength: 1000mg/ NDC: 68180-339-09 / Distribution Dates: 11/21/2018 - 05/27/2020

- Product: Metformin Hydrochloride Extended-Release Tablets USP/ Strength: 500mg/ NDC: 68180-336-07 / Distribution Dates: 11/05/2018 - 05/22/2020

- Product: Metformin Hydrochloride Extended-Release Tablets USP/ Strength: 1000mg/ NDC: 68180-337-07 / Distribution Dates: 11/05/2018 - 05/22/2020

Lupin Pharmaceuticals Inc. is notifying its wholesalers, distributors, drug chain, mail order pharmacies and supermarkets by phone and through recall notification and is arranging for the return of all the recalled product NDC’s.

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“Company name: Lupin Pharmaceuticals, Inc
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Reason of the recall: Detection of N-Nitrosodimethylamine (NDMA)
FDA Recall date: June 11, 2020
Recall details: Lupin Pharmaceuticals Inc. is voluntarily recalling Met ... See Moreformin Hydrochloride Extended-Release Tablets USP (generic equivalent of Fortamet®), 500mg, lot G901203 to the consumer level. FDA analysis revealed that this lot exceeded the Acceptable Daily Intake Limit for the impurity N-Nitrosodimethylamine (NDMA). To date, Lupin Pharmaceuticals Inc. has not received any reports of adverse events related to 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 and found in water and foods, including meats, dairy products and vegetables. Metformin Hydrochloride Extended-Release Tablets USP, 500mg is a prescription oral medication indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus. It is packaged in a bottle containing 60 tablets with NDC 68180-336-07. The affected lot of Metformin Hydrochloride Extended-Release Tablets USP, 500mg is included in below table:

- Product Name: Metformin Hydrochloride Extended-Release Tablets USP, 500mg

- NDC: 68180-336-07

- Lot Number: G901203

- Expiration Date: 12/2020

The product can be identified by the NDC and the lot number available on the side of the bottle label. Metformin Hydrochloride Extended-Release Tablets USP, 500mg was distributed nationwide in the USA to wholesalers, distributors, and mail order pharmacies.

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Transliquid Technologies LLC has accounted for and prevented distribution of a substantial majority of the product at the consumer level and is arranging for its return. Transliquid Technologies LLC is notifying its distributors and customers by email and first-class U.S. Mail and is arranging for the return of all recalled products. Consumers, distributors, and retailers that have Mystic Shield Protection hand sanitizer, which is being recalled, should stop using and return to the 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.

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Check the full recall details on fda.gov

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“Company name: Biota Biosciences, LLC
Brand name: Biota Biosciences
Product recalled: Cannabidiol (CBD) Complex, Curcumin Complex, Cannabidiol + Curcumin
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FDA Recall date: May 20, 2020
Recall details: Biota Biosciences is voluntarily recalling the followi ... See Moreng lots in the table below of Cannabidiol (CBD) Complex, Curcumin Complex, and Cannabidiol + Curcumin Injectables to the customer level. These injectable products are being recalled because they were marketed without FDA approval. The products claims on our website make these products unapproved new drugs. Further, the products are misbranded because the labeling fails to bear adequate directions for use.

- Product Name: Cannabidiol(CBD)Complex / Strength(mg): 40 / Multiple Dose Vial Size: 10 mL / Lot: 2H071219P / Expiration: 07/12/2021

- Product Name: Cannabidiol(CBD)Complex / Strength(mg): 500 / Multiple Dose Vial Size: 10 mL / Lot: 10102019P / Expiration: 10/10/2021

- Product Name: Curcumin Complex / Strength(mg): 40 / Multiple Dose Vial Size: 10 mL / Lot: 2H071219CCD / Expiration: 07/12/2021

- Product Name: Curcumin Complex / Strength(mg): 500 / Multiple Dose Vial Size: 10 mL / Lot: 0712019CCD / Expiration: 07/12/2021

- Product Name: Cannabidiol + Curcumin / Strength(mg): 500 / Multiple Dose Vial Size: 10 mL / Lot: 10102019PC / Expiration: 10/10/2021

Risk Statement: Unapproved new drugs injected into the bloodstream for which safety and efficacy have not been established could pose a serious risk of harm to users because they bypass many of the body’s natural defenses against toxic ingredients, toxins, or dangerous organisms that can lead to serious and life-threatening conditions such as septicemia or sepsis. Biota Biosciences has not received any reports of adverse events related to this recall.

Risk Statement: Unapproved new drugs injected into the bloodstream for which safety and efficacy have not been established could pose a serious risk of harm to users because they bypass many of the body’s natural defenses against toxic ingredients, toxins, or dangerous organisms that can lead to serious and life-threatening conditions such as septicemia or sepsis. Biota Biosciences has not received any reports of adverse events related to this recall.

Cannabidiol (CBD) Complex was marketed to suppress pain and aid in the detoxification processes as a promising therapeutic for a wide array of disorders such as epilepsy, including many challenging neuropathy conditions. Curcumin Complex was marketed as a potent anti-inflammatory and antioxidant that may also help improve symptoms of depression and arthritis. Cannabidiol + Curcumin was marketed as a more efficient therapeutic effect. The product was sold to certified practitioners who further administer to customers. The product is packaged in 10 mL sterile vials. Products were distributed Nationwide in the USA and one consignee in New Zealand.

Water Soluble 40mg/10m products can be identified by the labels attached.

Water Soluble 500mg/10m products can be identified by the labels attached.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User