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Fresenius Kabi USA Dexmedetomidine HCL in 0.9% Sodium Chloride Injection - recalled due to cross contamination with Lidocaine, USA

November 19, 2020 6:01 PM

United States

Company name: Fresenius Kabi USA
Brand name: Fresenius Kabi USA
Product recalled: Dexmedetomidine HCL in 0.9% Sodium Chloride Injection
Reason of the recall: Cross Contamination with Lidocaine
FDA Recall date: November 19, 2020
Recall details: Fresenius Kabi USA is voluntarily recalling a single lot of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg/50 mL (4 mcg /mL), 50 mL fill in a 50 mL vial. Fresenius Kabi initiated this recall due to a trace amount of lidocaine present in the lot. This recall is being performed to the user level. To date, no adverse drug experience reports have been received for the recalled lot. Administration of Dexmedetomidine HCl containing trace amounts of lidocaine to a patient with lidocaine allergy could result in a potentially life-threatening allergic reaction. 

Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection is approved for intravenous use and indicated for sedation of non-intubated patients prior to and/or during surgical and other procedures. Listed below is a table of the recalled lot distributed nationwide to wholesalers, distributors, hospitals and pharmacies between April 9, 2020 and April 13, 2020. An image of the label is also included below.

- Dexmedetomidine HCl in 0.9%. Sodium Chloride Injection, 200 mcg / 50 mL (4 mcg / mL), 50 mL fill in a 50 mL vial. NDC Number: 63323-671-50. Product Code: 671050. Batch number: 6123925. Expiration Date: 03/2022. First Ship Date: 04/09/2020. Last Ship Date: 04/13/2020

Fresenius Kabi is notifying its distributors and customers by letter and asking them to check their stock immediately and to quarantine and discontinue the use and distribution of any affected product.

Distributors should notify their customers and direct them to quarantine and discontinue distributing or dispensing any affected lots, and to return the product to Fresenius Kabi.

Customers with questions regarding this recall may contact Fresenius Kabi at 1-866-716-2459 Monday through Friday, during the hours of 8:00 a.m. to 5:00 p.m. Central Time. Consumers should contact their physician or health care provider if they have experienced any problems that may be related to taking or using this drug product.

Check the full recall details on fda.gov

Source: FDA

Reported By SafelyHQ.com User
More incidents from:
Drugs
Recall
United States

Related Reports

November 29, 2020 9:25 PM

“The FSA announced the recall of raw dog food products by Happy Hounds Wales Ltd because they may contain salmonella.

FSA advises consumers not to use the recalled product. Instead, return it to the store from where it was bought for a full refund. When handling and serving raw pet food it is alw... See Moreays advised to clean utensils and feeding bowls thoroughly after use.

- Frozen Beef Kidney (1kg). Batch code: 962. Best before: 10/26/2021
- Frozen Whole Heart (Individual Item). Batch code: 962. Best before: 10/26/2021
- Frozen Chicken and Beef Sleeve (1kg). Batch code: 1344/962. Best before: 11/2/2021
- Frozen Lamb and Beef Sleeve (1kg). Batch code: 962-966. Best before: 11/4/2021
- Frozen Diced Heart (1.5kg). Batch code: 962. Best before: 10/26/2021

Check the full recall details on food.gov.uk

Source: FSA
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Reported By SafelyHQ.com User

November 9, 2020 5:00 PM

“Company name: Lohxa, LLC
Brand name: Lohxa
Product recalled: Chlorhexidine Gluconate Oral Rinse USP, 0.12% Alcohol free
Reason of the recall: May be contaminated with Burkholderia lata
FDA Recall date: November 09, 2020
Recall details: Lohxa, LLC is voluntarily recalling Chlorhexidine Gluconat... See Moree Oral Rinse USP, 0.12% Alcohol free (NDC:70166-027-15) products bearing an expiration date from 01/31/21 – 03/31/21 (see specific lots below) to the consumer level. This product is sourced and repackaged from Sunstar Americas Inc. who has notified us the product may be contaminated with the bacteria Burkholderia lata.

Use of the defective product in the immunocompetent host may result in oral and, potentially, systemic infections requiring antibacterial therapy. In the most at-risk populations, the use of the defective product may result in life-threatening infections, such as pneumonia and bacteremia. To date, no adverse events have been reported to Lohxa, LLC related to this recall.

The prescription oral rinse product, available through institutional use only, is indicated for use as part of a professional program for the treatment of gingivitis and is packaged as follows:

- Chlorhexidine Gluconate Oral Rinse USP, 0.12% Alcohol free is distributed in cases each containing 50 unit dose cups. Each case contains a colored label around the lid and body of the case.

The product can be identified by as shown in the images below. Chlorhexidine Gluconate Oral Rinse USP, 0.12% Alcohol free was distributed to Nationwide to hospital pharmacies. Lohxa, LLC is notifying its direct customers by Fedex overnight mail, electronic mail, phone call and is arranging for return of all recalled products.

Patients, pharmacies, and healthcare facilities in possession of these products should stop using and dispensing immediately. Consumers with questions regarding this recall can contact Lohxa, LLC by phone at 1-800-641-5564 or email info@lohxa.com on Monday-Friday from 8am-5pm EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this drug product. Affected products and lot numbers follow below:

- Chlorhexidine Gluconate Oral Rinse USP, 0.12% Alcohol free, 15 mL (NDC:70166-027-15) LOT/ EXP: T09101A/01/2021 |T08292A/02/2021 |T10011A/02/2021 |M10193A/03/2021 |T10223A/03/2021

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

November 3, 2020 10:00 AM

“Company name: Nostrum Laboratories
Brand name: Nostrum Laboratories
Product recalled: Metformin HCl Extended Release Tablets, USP 500 mg
Reason of the recall: NDMA exceeds acceptable daily intake limit
FDA Recall date: November 03, 2020
Recall details: Nostrum Laboratories, Inc. is voluntarily... See Morerecalling 2 (two) lots of Metformin HCl Extended Release Tablets, USP 500 mg to the consumer level. The Metformin HCl Extended Release Tablets, USP 500 mg have been found to contain levels of nitrosamine impurities above the ADI limit of 96 ng/day as published in the FDA Guidance Document issued September, 2020.

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. Nostrum Laboratories, Inc. has not received any reports of adverse events related to this recall.

The product 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 HDPE bottles of 100 tablets, under NDC 29033-055-01. The affected Metformin HCl Extended Release Tablets, USP 500 mg lots are listed in the table below. The product can be identified as an off-white oblong tablet debossed with “NM5”. Metformin HCl Extended Release Tablets, USP 500 mg was distributed Nationwide to wholesalers.

- Metformin HCl Extended Release Tablets, USP 500 mg. NDC: 29033-055-01 (center panel). Lot Numbers - Expiry Dates: MET100201 - 05/2022. MET100401 - 05/2022

Nostrum Laboratories, Inc. is notifying its distributors by letter and is arranging for return of all recalled products. Pharmacies that have Metformin HCl Extended-Release Tablets, USP 500 mg which is being recalled should return to place of purchase. Consumers should consult a healthcare professional to obtain a replacement or a different treatment option. It could be dangerous for patients with type 2 diabetes to stop taking their metformin without first talking to their healthcare professional. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking this drug product.

Consumers with medical questions regarding this recall can contact Nostrum Laboratories, Inc. Medical Affairs at phone number 816-308-4941 Monday through Friday from 8am – 5 pm CST. Consumers should contact their physician or pharmacy for further medical advice.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

November 2, 2020 4:00 PM

“Company name: Nostrum Laboratories
Brand name: Nostrum Laboratories
Product recalled: Metformin HCl Extended Release Tablets, USP 750 mg
Reason of the recall: NDMA exceeds acceptable daily intake limit
FDA Recall date: November 02, 2020
Recall details: Kansas City, Missouri, Nostrum Laborator... See Moreies, Inc. is voluntarily recalling 2 (two) lots of Metformin HCl Extended Release Tablets, USP 750 mg to the consumer level. The Metformin HCl Extended Release Tablets, USP 750 mg have been found to contain levels of nitrosamine impurities above the ADI limit of 96 ng/day as published in the FDA Guidance Document issued September, 2020.

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. Nostrum Laboratories, Inc. has not received any reports of adverse events related to this recall.

The product 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 HDPE bottles of 100 tablets, under NDC 29033-056-01. The affected Metformin HCl Extended Release Tablets, USP 750 mg lots are listed in the table below. The product can be identified as an off-white oblong tablet debossed with “NM7”. Metformin HCl Extended Release Tablets, USP 750 mg was distributed Nationwide to wholesalers.

- Metformin HCl Extended Release Tablets, USP 750 mg. NDC: 29033-056-01. Lot Numbers: MET200101 05/2022 | MET200301 05/2022

Nostrum Laboratories, Inc. is notifying its distributors by letter and is arranging for return of all recalled products. Pharmacies that have Metformin HCl Extended Release Tablets, USP 750 mg which is being recalled should return to place of purchase. Consumers should consult a healthcare professional to obtain a replacement or a different treatment option. It could be dangerous for patients with type 2 diabetes to stop taking their metformin without first talking to their healthcare professional. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking this drug product.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

October 28, 2020 11:00 AM

“Company name: Sunstar Americas, Inc.
Brand name: Paroex
Product recalled: Paroex Chlorhexidine Gluconate Oral Rinse, 4 oz and 16 oz
Reason of the recall: Potential contamination with Burkholderia lata
FDA Recall date: October 28, 2020
Recall details: Sunstar Americas, Inc. (SAI) is voluntarily... See Morerecalling Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% products bearing an expiration date from 6/30/22 – 9/30/22 (see specific lots below) to the consumer level. This product may be contaminated with the bacteria Burkholderia lata.

Use of the defective product in the immunocompetent host may result in oral and, potentially, systemic infections requiring antibacterial therapy. In the most at-risk populations, the use of the defective product may result in life-threatening infections, such as pneumonia and bacteremia. To date, no adverse events have been reported to SAI related to this recall. The prescription oral rinse product, available through healthcare professionals only, is indicated for use as part of a professional program for the treatment of gingivitis and is packaged as follows:

- 1789P GUM® Paroex® is distributed in cases each containing 6 amber bottles of 16 fluid ounce (473 ml) chlorhexidine rinse. The bottle has a childproof cap and a 15 ml metered dosage cup, is safety sealed, and is decorated with a multiple-panel wrap-around label.
- 1788P GUM® Paroex® is distributed in cases each containing 24 amber bottles of 4 fluid ounce (118.25 ml) chlorhexidine rinse. The bottle has a childproof cap, is safety sealed, and is decorated with a multiple-panel wrap-around label.

The product can be identified by as shown in the images below: Paroex was distributed Nationwide to Dental offices, Dental distributors, Pharmaceutical wholesalers, Dental schools, and Pharmacies. SAI is notifying its direct distributors and customers by USPS Priority mail and is arranging for return of all recalled products. Patients, pharmacies, and healthcare facilities in possession of these products should stop using and dispensing immediately.

Consumers with questions regarding this recall can contact SAI by phone at 1-800-528-8537 or email us.pcr@us.sunstar.com on Monday-Friday from 8am-5pm CST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this drug product. Affected products and lot numbers are detailed in the link below.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

October 14, 2020 9:00 PM

“Company name: Hadson Toko Trading Co., Inc.
Brand name: Eishindo
Product recalled: Jelly Cups
Reason of the recall: Product poses a choking hazard.
FDA Recall date: October 14, 2020
Recall details: HADSON (TOKO) TRADING CO., INC. OF MASPETH, NY is recalling its 28.2oz (800g) bags of EISHINDO MI... See MoreNI CUP JELLY (50 pcs) (迷你果凍杯(大)) due to the product being a potential choking hazard based off of its product size and consistency. Small jelly cups have previously been implicated in choking deaths of children.

The recalled jelly cups were distributed nationwide in retail food stores and are sold in large clear bags of 50 jelly cups. The UPC code is, “4970481000034,” Product code is, “E007.” No incidents of consumers choking have been reported to date in connection with this product. The potential choking hazard was noted after discussion with a representative from the Food and Drug Administration.

Consumers who have purchased 28.2oz (800g) bags of EISHINDO MINI CUP JELLYS are urged to return them to the store where they were purchased for a full refund or throw them away in a sealed package inside a secure garbage can with a tight fitting lid. Consumers who have questions or concerns may contact the company at 718-628-6761 Monday thru Friday between 8AM and 6PM EST.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

October 5, 2020 2:00 PM

“Company name: Marksans Pharma Limited
Brand name: Time-Cap Labs Inc.
Product recalled: Metformin Hydrochloride for Extended-Release Tablets, USP 500 mg and 700 mg
Reason of the recall: Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity
FDA Recall date: October 05, 2020
Recall detai... See Morels: Marksans Pharma Limited, India is voluntarily expanding its earlier initiated recall on June 05, 2020 to include an additional 76 unexpired lots of Metformin Hydrochloride Extended-Release Tablets, USP 500mg, & 750mg to the consumer level. Marksans performed N-Nitrosodimethylamine (NDMA) testing of unexpired identified marketed lots and observed that NDMA content in some lots is exceeding the acceptable Daily Intake Limit (ADI) of 96ng/day, therefore, out of an abundance of caution, an additional 76 lots are being recalled.

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 that have been related to this recall. Metformin Hydrochloride Extended-Release Tablets, USP 500mg & 750mg are indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus and is packaged in HDPE bottles with the following NDC#s in different packing configurations
- Metformin Hydrochloride Extended-Release Tablets, USP 500mg:
90 counts: 49483-623-09
100 counts: 49483-623-01
500 counts: 49483-623-50
1000 counts: 49483-623-10
- Metformin Hydrochloride Extended-Release Tablets, USP 750mg:
100 counts: 49483-624-01

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 and Metformin Hydrochloride Extended-Release Tablets, USP 750mg, are white to off white, capsule shaped, biconvex tablets, debossed with ‘102’ on one side and plain on the other side.

Metformin Hydrochloride Extended-Release Tablets, USP 500mg & 750 mg were distributed by Time-Cap Labs, Inc. (located at 7 Michael Avenue, Farmingdale, New York 11735) 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 lots. Distributors //customers that have affected lots of Metformin Hydrochloride Extended- Release Tablets, USP 500mg & 750mg those are being recalled should return to place of purchase. The lot # can be located on the side panel of bottle labels as well as shipper/case labels.

Consumers with questions regarding this recall and return can contact Ms. Irene McGregor (Vice President, Regulatory Affairs) of Time-Cap Labs, Inc., located at 7 Michael Avenue, Farmingdale, New York 11735, by phone number 631-753-9090; ext. 160, [Monday to Friday 8am-5pm EST] or e-mail address imcgregor@timecaplabs.com.

Consumers taking these recalled product lots of Metformin ER Tablets should continue taking it until a doctor or pharmacist gives them a replacement or a different treatment option. It could be dangerous for patients with type 2 diabetes to stop taking their metformin without first talking to their health care professional. Consumer 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.

Check the full recall details and list of products on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

October 2, 2020 5:00 PM

“Company name: Ashtel Studios
Brand name: Smart Care
Product recalled: Hand sanitizer packaged in 0.84 oz. pouches
Reason of the recall: Product is packaged in containers resembling a food and drink pouch
FDA Recall date: October 02, 2020
Recall details: Company Announcement Ashtel Studios has a... See Morennounced a voluntary recall of all lots of licensed hand sanitizer packaged in .84 oz containers resembling food and drink pouches labeled with various children’s characters listed in the table below to the consumer level.

The products are being recalled because they are packaged in containers resembling food and drink pouch. The recall does not affect any other Hand Sanitizer products from Ashtel Studios.

Product Size NDC
PAW Patrol Hand Sanitizer 0.84 FL. OZ (25 mL) 70108-042-01
JoJo Siwa Hand Sanitizer 0.84 FL. OZ (25 mL) 70108-044-01
Hot Wheels Hand Sanitizer 0.84 FL. OZ (25 mL) 70108-045-01
Barbie Hand Sanitizer 0.84 FL. OZ (25 mL) 70108-046-01
Trolls Hand Sanitizer 0.84 FL. OZ (25 mL) 70108-047-01
Minions Hand Sanitizer 0.84 FL. OZ (25 mL) 70108-043-01

Ingesting hand sanitizer, which is intended for topical use, could potentially result in alcohol toxicity. Symptoms of alcohol toxicity may range from lack of coordination, slowed or slurred speech, drowsiness to coma, which can be fatal. Furthermore, ingesting alcohol can affect the brain and cause impaired driving or operating heavy machinery. Alcohol can also interact with numerous drugs which may result in serious adverse effects. Ingesting alcohol by people with alcohol addiction may interfere with maintaining abstinence. Additionally, people with alcohol addiction may seek large amounts of ethanol-based hand sanitizers as a substitute. Ashtel Studios has received no reports of adverse reactions.

The product is intended to be applied topically to help reduce bacteria on the skin that could cause diseases when soap and water are not available and is packaged in 0.84 oz pouches. The product can be identified by examples of the products pictured below. Product was distributed to selected retailers in the United States and Canada.

Ashtel Studios has provided written notification to its distributors and retailers and is alerting customers via this voluntary recall. While the product is not available for purchase, if a consumer has product which is being recalled they are advised to destroy it immediately.

Check the full recall details on fda.gov
Source: FDA
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Reported By SafelyHQ.com User

September 23, 2020 3:00 PM

“Company name: Sun Pharmaceutical Industries
Brand name: Riomet ER
Product recalled: Metformin Hydrochloride for Extended-Release Oral Suspension
Reason of the recall: Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity
FDA Recall date: September 23, 2020
Recall details: Sun Pharmace... See Moreutical Industries, Inc. (SUN PHARMA), a wholly owned subsidiary of Sun Pharmaceutical Industries Ltd. is voluntarily recalling one lot of RIOMET ER™ (metformin hydrochloride for extended-release oral suspension), 500 mg per 5 mL to the consumer level.  The reason for the recall is due to the level of N-Nitrosodimethylamine (NDMA), which has been found to be above the allowable Acceptable Daily Intake (ADI) limit established by the U.S. Food and Drug Administration. 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.  To date, SUN PHARMA has not received any reports of adverse events related to this recall.  RIOMET ER™ (metformin hydrochloride for extended-release oral suspension) is a prescription oral medication indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.  RIOMET ER™, when reconstituted, is packaged in a 16 oz. (473 mL) round bottle.  Each carton contains one bottle of drug pellets, one bottle of diluent, and one dosing cup.  The affected RIOMET ER™ is the following lot:

- RIOMET ER™ (metformin hydrochloride for extended-release oral suspension) 500 mg per 5 mL. Lot # AB06381. NDC #10631-019-17. Expiration Date: 10/2021. Number of Units: 747 cartons.

The product can be identified by the bottles or carton labeled as RIOMET ER™ (metformin hydrochloride for extended-release oral suspension), containing the specific Lot Number and Expiration Date referenced above or on the labeling below. The product was distributed nationwide to wholesale customers.

SUN PHARMA is notifying its distributors and customers through its third-party Recall Coordinator (Inmar Inc.), via FedEx standard overnight shipping and will arrange for return of all recalled products.

Distributors and retailers that have RIOMET ER™ (metformin hydrochloride for extended release oral suspension), which is being recalled, should stop distributing and return it to place of purchase or as directed in the recall notification.

Patients taking RIOMET ER™ (metformin hydrochloride for extended-release oral suspension), 500 mg per 5 mL are advised to continue taking their medication and contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment. According to the U.S. 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. Please visit the agency’s website for more information at fda.gov

Consumers with questions regarding this recall can contact SUN PHARMA by calling 1-800-818-4555 Monday through Friday between 8:00 am to 5:00 pm EST or e-mailing drug.safetyUSA@sunpharma.com. 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.

Check the full recall details on fda.gov

Source: FDA
See Less
Reported By SafelyHQ.com User

An Employee test positive for Covid-19, Berkeley Springs High School, Concord Avenue, Berkeley Springs, WV, USA

Berkeley Springs High School, Concord Avenue, Berkeley Springs, WV, USA

November 30, 2020 12:00 PM

“An employee at Berkeley Springs High School located on Concord Avenue in Berkeley Springs recently tested positive for Covid-19

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

Recent Interesting Reports

November 23, 2020 2:00 PM

“Company name: Fusion Health and Vitality LLC
Brand name: CORE, Immune Boost
Product recalled: CORE essential nutrients and Immune Boost Sublingual Vitamin D3
Reason of the recall: Unapproved new drug
FDA Recall date: November 23, 2020
Recall details: Fusion Health and Vitality LLCis voluntaril... See Morey recalling all 2020 Lots of CORE essential nutrients and Immune Boost Sublingual Vitamin D3. CORE has been found to contain an unapproved food additive, hordenine HCl, rendering it adulterated. Immune Boost Labeling was found to contain statements that caused it to become and unapproved new drug under FDA labeling laws. Hordenine HCl is possibly unsafe when taken by mouth. Hordenine HCl might have similar stimulant effects and side effects such as rapid heart rate and high blood pressure.

Fusion Health and Vitality LLC has not received any reports of adverse events related to this recall.  Please review the attached photos for identification. We began shipping Core Essential Nutrients on 1/2/2020 and we began shipping Immune Boost Sublingual Vitamin D3 on 4/15/2020. Both products are packaged with labels which prominently display the product name.  CORE essential nutrients are found in a dark colored jar, in powdered format. 

This product was formulated to mix into a liquid before consumption. The Immune Boost sublingual was packaged in a 2 ounce bottle that came with a sublingual application dropper. Fusion Health and Vitality is notifying its customers by email and is arranging for return of all recalled products. Consumers that have product which is being recalled should stop using it and return it to Fusion Health and Vitality for destruction. Consumers with questions regarding this recall or how to return recalled product can contact Fusion Health and Vitality by calling 1-888-964-5327, 9am to 5pm, Monday Thru Friday, EST. 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.

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

November 15, 2020 8:18 PM

“They are practically forcing people to put hand sanitizer on their hands even though they are not required to do so. I am allergic to some of the stuff because I don't know what's in their hand sanitizer and my hands got all cracked and chapped. They still practically forced people to do it even tho... See Moreugh there's no law. See Less
Reported By SafelyHQ.com User

November 9, 2020 5:00 PM

“Company name: Lohxa, LLC
Brand name: Lohxa
Product recalled: Chlorhexidine Gluconate Oral Rinse USP, 0.12% Alcohol free
Reason of the recall: May be contaminated with Burkholderia lata
FDA Recall date: November 09, 2020
Recall details: Lohxa, LLC is voluntarily recalling Chlorhexidine Gluconat... See Moree Oral Rinse USP, 0.12% Alcohol free (NDC:70166-027-15) products bearing an expiration date from 01/31/21 – 03/31/21 (see specific lots below) to the consumer level. This product is sourced and repackaged from Sunstar Americas Inc. who has notified us the product may be contaminated with the bacteria Burkholderia lata.

Use of the defective product in the immunocompetent host may result in oral and, potentially, systemic infections requiring antibacterial therapy. In the most at-risk populations, the use of the defective product may result in life-threatening infections, such as pneumonia and bacteremia. To date, no adverse events have been reported to Lohxa, LLC related to this recall.

The prescription oral rinse product, available through institutional use only, is indicated for use as part of a professional program for the treatment of gingivitis and is packaged as follows:

- Chlorhexidine Gluconate Oral Rinse USP, 0.12% Alcohol free is distributed in cases each containing 50 unit dose cups. Each case contains a colored label around the lid and body of the case.

The product can be identified by as shown in the images below. Chlorhexidine Gluconate Oral Rinse USP, 0.12% Alcohol free was distributed to Nationwide to hospital pharmacies. Lohxa, LLC is notifying its direct customers by Fedex overnight mail, electronic mail, phone call and is arranging for return of all recalled products.

Patients, pharmacies, and healthcare facilities in possession of these products should stop using and dispensing immediately. Consumers with questions regarding this recall can contact Lohxa, LLC by phone at 1-800-641-5564 or email info@lohxa.com on Monday-Friday from 8am-5pm EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this drug product. Affected products and lot numbers follow below:

- Chlorhexidine Gluconate Oral Rinse USP, 0.12% Alcohol free, 15 mL (NDC:70166-027-15) LOT/ EXP: T09101A/01/2021 |T08292A/02/2021 |T10011A/02/2021 |M10193A/03/2021 |T10223A/03/2021

Check the full recall details on fda.gov

Source: FDA
See Less
Reported By SafelyHQ.com User

November 19, 2020 6:01 PM

“Company name: Fresenius Kabi USA
Brand name: Fresenius Kabi USA
Product recalled: Dexmedetomidine HCL in 0.9% Sodium Chloride Injection
Reason of the recall: Cross Contamination with Lidocaine
FDA Recall date: November 19, 2020
Recall details: Fresenius Kabi USA is voluntarily recalling a singl... See Moree lot of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg/50 mL (4 mcg /mL), 50 mL fill in a 50 mL vial. Fresenius Kabi initiated this recall due to a trace amount of lidocaine present in the lot. This recall is being performed to the user level. To date, no adverse drug experience reports have been received for the recalled lot. Administration of Dexmedetomidine HCl containing trace amounts of lidocaine to a patient with lidocaine allergy could result in a potentially life-threatening allergic reaction. 

Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection is approved for intravenous use and indicated for sedation of non-intubated patients prior to and/or during surgical and other procedures. Listed below is a table of the recalled lot distributed nationwide to wholesalers, distributors, hospitals and pharmacies between April 9, 2020 and April 13, 2020. An image of the label is also included below.

- Dexmedetomidine HCl in 0.9%. Sodium Chloride Injection, 200 mcg / 50 mL (4 mcg / mL), 50 mL fill in a 50 mL vial. NDC Number: 63323-671-50. Product Code: 671050. Batch number: 6123925. Expiration Date: 03/2022. First Ship Date: 04/09/2020. Last Ship Date: 04/13/2020

Fresenius Kabi is notifying its distributors and customers by letter and asking them to check their stock immediately and to quarantine and discontinue the use and distribution of any affected product.

Distributors should notify their customers and direct them to quarantine and discontinue distributing or dispensing any affected lots, and to return the product to Fresenius Kabi.

Customers with questions regarding this recall may contact Fresenius Kabi at 1-866-716-2459 Monday through Friday, during the hours of 8:00 a.m. to 5:00 p.m. Central Time. Consumers should contact their physician or health care provider if they have experienced any problems that may be related to taking or using this drug product.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

November 29, 2020 9:25 PM

“The FSA announced the recall of raw dog food products by Happy Hounds Wales Ltd because they may contain salmonella.

FSA advises consumers not to use the recalled product. Instead, return it to the store from where it was bought for a full refund. When handling and serving raw pet food it is alw... See Moreays advised to clean utensils and feeding bowls thoroughly after use.

- Frozen Beef Kidney (1kg). Batch code: 962. Best before: 10/26/2021
- Frozen Whole Heart (Individual Item). Batch code: 962. Best before: 10/26/2021
- Frozen Chicken and Beef Sleeve (1kg). Batch code: 1344/962. Best before: 11/2/2021
- Frozen Lamb and Beef Sleeve (1kg). Batch code: 962-966. Best before: 11/4/2021
- Frozen Diced Heart (1.5kg). Batch code: 962. Best before: 10/26/2021

Check the full recall details on food.gov.uk

Source: FSA
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Reported By SafelyHQ.com User
Doctor Visit: Yes
Diagnosis: Salmonella

Covid-19 OSHA Complaint, iTow Towing, 23642 Vía Fabricante, Mission Viejo, CA 92691, USA

iTow Towing, 23642 Vía Fabricante, Mission Viejo, CA 92691, USA

November 10, 2020 12:00 PM

“T8 CCR § 3203(a)(2) ¿ Facial coverings mandate not enforced in the workplace. Employees and patrons concerned with potential exposure to Covid-19 at the workplace.

Alleged Hazards: 1, Employees Exposed: 5
Source: Osha.gov | Receipt Date: 2020-10-13 See Less
Reported By SafelyHQ.com User

Covid-19 OSHA Complaint, Northern Pride Inc, 518 Pennington Ave S, Thief River Falls, MN 56701, United States

Northern Pride Inc, 518 Pennington Ave S, Thief River Falls, MN 56701, United States

November 10, 2020 12:00 PM

“There are at least six positive COVID-19 cases at the facility and the company is not having employees who worked in close proximity to these employees quarantined.


Source: Osha.gov | Receipt Date: 2020-10-19 See Less
Reported By SafelyHQ.com User

Covid-19 OSHA Complaint, Taste of Sicily, 132 East Main Street, Palmyra, PA 17078, USA

Taste of Sicily, 132 East Main Street, Palmyra, PA 17078, USA

November 10, 2020 12:00 PM

“The employer has not implemented a good infection control plan including things such as face coverings for employees, training, social distancing, etc. Refer to the Centers for Disease Control CDC guidance for employers at this link. cdc.gov... See Morebusinesses-employers.html OSHA in coordination with the Department of Health and Human Services has prepared Guidance on Preparing Workplaces for COVID-19. It can be found here: osha.gov OSHA has Guidance on Returning to Work osha.gov

Alleged Hazards: 1, Employees Exposed: 1
Source: Osha.gov | Receipt Date: 2020-08-03
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Reported By SafelyHQ.com User

Covid-19 OSHA Complaint, Mortenson Construction, 12918 Orange Plank Road, Locust Grove, VA 22508, USA

Mortenson Construction, 12918 Orange Plank Road, Locust Grove, VA 22508, USA

November 18, 2020 12:00 PM

“1. It is alleged employees are reporting to work with symptoms of COVID-19 and are allowed to remain at work. 2. It is alleged employees are not wearing a face covering when working within 6' of others and if they do, it is not being worn properly over both the nose and mouth to prevent the spread o... See Moref COVID-19. The wearing of a facemask is not enforced. 3. It is alleged thin painters plastic is in place in cars, work trucks, vans, etc., and the barriers are becoming contaminated as employees are not cleaning and disinfecting between other groups of employees riding in the vehicles. 4. It is alleged this painter plastic that is in place in vehicles is causing a visibility problem for the drivers. 5. It is alleged the cleaning products being used to sanitize equipment, etc., is so diluted that it does not kill the virus which causes COVID-19. 6. It is alleged employees are congregating together such as in trailers, at picnic tables and are not social distancing.

Alleged Hazards: 6, Employees Exposed: 620
Source: Osha.gov | Receipt Date: 2020-09-29
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Reported By SafelyHQ.com User

Covid-19 OSHA Complaint, Parts Authority Robinwood, 6161 Robinwood Rd, Baltimore, MD 21225, United States

Parts Authority Robinwood, 6161 Robinwood Rd, Baltimore, MD 21225, United States

November 25, 2020 12:00 PM

“Locations - Buildings 6101 and 6161. Possibly employees are exposed to COVID-19 where personal protective equipment (PPE) was not provided. Possibly employees are exposed to COVID-19 where chemicals used for disinfecting was not provided. Possibly employees exposed to electrical hazard as a result o... See Moref temporary wiring used in lieu of permanent wiring. Possibly employees exposed to tripping and struck by hazards as a result of poor housekeeping and low hanging wires. Possibly employees exposed to fall hazards by using ladders unable to reach elevated highs. Possibly employees exposed to inadequate lighting in aisleways. Possibly employees exposed to crushing hazards as a result of the lack of foot protection not required while using carts weighing up to approximately 75 pounds. Possibly employees exposed to egress hazards by possible blocked exits.


Source: Osha.gov | Receipt Date: 2020-05-20
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Reported By SafelyHQ.com User