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Fresenius Kabi USA Ketorolac Tromethamine Injection, USP, 30 mg/mL - recalled due to Presence of particulate matter, USA

January 8, 2021 6:01 PM

United States

Company name: Fresenius Kabi USA
Brand name: Fresenius Kabi
Product recalled: Ketorolac Tromethamine Injection, USP, 30 mg/mL
Reason of the recall: Presence of particulate matter
FDA Recall date: January 08, 2021
Recall details: Fresenius Kabi USA is voluntarily recalling a single lot of Ketorolac Tromethamine Injection, USP, 30 mg/mL, 1 mL fill in a 2 mL amber vial to the user level due to the presence of particulate matter. Particulate matter was found in reserve sample vials. No adverse event reports have been received for the recalled lot, which was produced and sold in 2019.

Administration of products containing particulate matter could obstruct blood vessels and result in local irritation of blood vessels, swelling at the site of injection, a mass of tissue that could become inflamed and infected, blood clots traveling to the lung, scarring of the lung tissues, and allergic reactions that could lead to life-threatening consequences.

Ketorolac Tromethamine, a nonsteroidal anti-inflammatory drug, is indicated for the short-term (up to 5 days in adults) management of moderately severe acute pain that requires analgesia at the opioid level. The total combined duration of use of oral Ketorolac Tromethamine and Ketorolac Tromethamine Injection should not exceed 5 days. Listed below is a table of the recalled lot distributed nationwide in the United States to wholesalers, distributors, hospitals, and pharmacies between March 28, 2019 and September 3, 2019.

Product Name/Product size: Ketorolac Tromethamine Injection, USP, 30mg / mL, 1 mL fill in a 2 mL amber vial
NDC Number: 63323-162-01
Product Code: 160201
Batch Number: 6121083
Expiration Date: 02/2021
First Ship Date: 03/28/2019
Last Ship Date: 09/03/2019

Fresenius Kabi is notifying its distributors and customers by letter and asking customers and distributors 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 the affected lot, and to return the product to Fresenius Kabi.

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

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

Related Reports

December 28, 2020 8:00 PM

“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: December 28, 2020
Recall details: Schaumburg, Illinois, Sunstar Americas, I... See Morenc. (SAI) is voluntarily recalling Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% products bearing an expiration date from 12/31/2020 – 9/30/2022 to the consumer level. This product may be contaminated with the bacteria Burkholderia lata. This is an expansion of the recall initially announced on October 27, 2020. 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, 29 adverse events have been reported to SAI related to this recall. Affected patients tested positive for Burkholderia lata infections, typically found in sputum cultures while under treatment for other serious medical conditions. Use of the contaminated product on patients with pre-existing respiratory conditions, including those infected with Covid-19, is particularly unsafe.

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 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 follow below:

-Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% Size/ Form: 16 fl.oz. Amber Bottles. NDC #: 052376-021-02. Product Code: 1789P. Lots Recalled: ALL LOTS with expiration date from Dec. 31, 2020 through Sep. 30, 2022

- Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% Size/ Form: 4 fl.oz. Amber Bottles NDC #: 052376-021-04. Product Code: 1788P. Lots Recalled: ALL LOTS with expiration date from Dec. 31, 2020 through Sep. 30, 2022.

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 Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178. Sunstar is committed to delivering safe, fully compliant products of the highest quality and is taking necessary steps to prevent future occurrence of this issue. 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

January 1, 2021 9:01 PM

“Company name: Precision Dose Inc.
Brand name: GUM Paroex
Product recalled: Paroex Chlorhexidine Gluconate Oral Rinse, 15 mL unit dose cups
Reason of the recall: Potential contamination with Burkholderia lata
FDA Recall date: December 31, 2020
Recall details: Company Announcement Precision Dose,... See MoreInc. is voluntarily recalling all lots of Chlorhexidine Gluconate Oral Rinse USP, 0.12%, 15mL Unit Dose Cups bearing an expiration date from 1/31/2021 – 02/28/2022 (see specific lots below) to the consumer level. Precision Dose, Inc. was notified by the manufacturer of the product, Sunstar Americas, Inc., that this product may be contaminated with the bacteria Burkholderia lata.

From information provided by the manufacturer, Sunstar Americas, Inc., 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 pneumonia and bacteremia.

To date, no adverse events have been reported to Precision Dose, Inc. 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 the product impacted is:

- Distributed in cases each containing 3 shrink-wrapped plastic trays each with 10 unit dose cups, 30-pack. NDC 68094-028-62
- Distributed in cases each containing 10 shrink-wrapped plastic trays each with 10 unit dose cups, 100-pack. NDC 68094-028-61

Chlorhexidine Gluconate Oral Rinse was distributed nationwide in the USA to pharmaceutical wholesalers. Precision Dose, Inc. is notifying its consignees directly and is arranging for return of all recalled product. Patients, pharmacies, and healthcare facilities in possession of these products should stop using and dispensing immediately.

Consumers with questions regarding this recall can contact Precision Dose, Inc. at 1 (800) 397-9228 (Monday-Friday, 8:00 AM to 4:30 PM Central Time) or by email to customercare@precisiondose.com. Consumers should contact their physician or healthcare provider if they have experienced problems that may be related to using this drug product. Affected products and lot numbers follow below: AFFECTED LOTS-Chlorhexidine Gluconate Oral Rinse USP, 0.12%

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

January 4, 2021 11:00 AM

“Company name: Essaar Inc.
Brand name: Soho Fresh
Product recalled: 70% Rubbing Alcohol
Reason of the recall: Contaminated with Methanol
FDA Recall date: January 04, 2021
Recall details: Company Announcement Essaar Inc. is voluntarily recalling lot 200528303 of Soho Fresh 70% Rubbing Alcohol... See Morein 33.81 oz. clear plastic bottles to the consumer level. FDA analysis of the product revealed it is contaminated with methanol. Substantial methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death. Although all persons using these products on their hands are at risk, young children who accidently ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk for methanol poisoning.

To date, Essar Inc. has not received any reports of adverse events related to this recall. The product is used as an external purpose use rubbing alcohol and is packaged in 33.81 oz. clear plastic bottles with lot number 200528303 and UPC 7502268987367.

Soho Fresh was distributed nationwide to retail stores. Essaar Inc. is notifying its distributors and customers by email and mail and is arranging for the return of all recalled product to Essaar Inc. Consumers that have product which is being recalled should stop using and discard or return to place of purchase or to Essaar Inc. contacting via email or phone or mailing address mentioned above for arrangements of return. Consumers who have purchased this product should not open the package or use the contents. Instead, they should return the product to the location of purchase for a full refund or call Essaar Inc. at 201-647-7606 Monday to Friday 9am to 5pm, Eastern Standard Time. Essaar Inc. can also be reached via email at essaarinc@yahoo.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. 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.

Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. FDA’s update  

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

January 4, 2021 9:01 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: January 04, 2021
Recall details: Company Announcement Nostrum Laboratories... See More, Inc. is voluntarily recalling one lot of Metformin HCl Extended Release Tablets, USP 750 mg (generic equivalent to Glucophage Tablets) to the consumer level. The Metformin HCl Extended Release Tablets, USP 750 mg (generic equivalent to Glucophage Tablets) 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. This is an expansion of the recall initially announced on November 2, 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. To date, 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 (generic equivalent to Glucophage Tablets) lot is 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 (generic equivalent to Glucophage Tablets) was distributed Nationwide to wholesalers.
Check the full recall details on fda.gov
Source: FDA
See Less
Reported By SafelyHQ.com User

January 17, 2021 11:59 PM

“The FSA announced the recall of several dog food products by Mars Petcare UK because they may contain high levels of vitamin D which exceed the maximum permitted intake.

FSA advises pet owners that if they have bought any of the following dog food products, you should stop feeding them to your do... See Moreg and contact Mars Petcare Customer Service at 0800 013 3131. If you have concerns that your pet may be showing symptoms of illness after eating one of the affected products, please contact a veterinarian.

- CHAPPIE Complete Chicken & Wholegrain Dry Dog Food (3kg). Batch code: 045F9MIN05. Best before: 44692
- PEDIGREE Mixer Adult Dry Dog Original (3kg). Batch code: 046E9MIN05 | 046F9MIN05 | 048A9MIN05. Best before: 12 February 2022 | 20 February 2022 | 22 February 2022
- PEDIGREE Mixer Adult Dry Dog Food Original (10kg). Batch code: 046E9MIN08 | 047C9MIN08. Best before: 12 February 2022 | 17 February 2022
- PEDIGREE Adult Complete Dry Dog Food with Chicken & Vegetables (12kg). Batch code: 046C9MIN08 | 046D9MIN08 | 046E9MIN08. Best before: 10 February 2022 | 11 February 2022 | 12 February 2022
- PEDIGREE Adult Complete Dry Dog Food with Chicken & Vegetables (2.6kg). Batch code: 045F9MIN05 | 047A9MIN05. Best before: 06 February 2022 | 15 February 2022

High levels of vitamin D fed to a pet over a short period (weeks/months) should not cause undue concern. Over a longer period of feeding, ingestion of elevated levels can lead to potential dog health issues. Vitamin D, when consumed at very high levels, can lead to serious health issues in dogs including renal dysfunction.

Check the full recall details on the FSA website food.gov.uk

Source: FSA
See Less
Reported By SafelyHQ.com User

Pfizer Vaccine, no side effects, South Hills Rehabilitation Center, East 28th Avenue, Eugene, OR, USA

South Hills Rehabilitation Center, East 28th Avenue, Eugene, OR, USA

January 21, 2021 10:17 PM

“Received first shot 3 weeks ago, had no effects at all, didn't realize that I even had a shot. Due for second shot January 24 2021 , shot was given by South Hills Rehab in Eugene, Oregon See Less
Reported By SafelyHQ.com User

COVID-19 Vaccine, Coatesville, IN, USA

Symptoms: Fever Headache Fatigue Body Ache
Coatesville, IN, USA

January 21, 2021 8:47 PM

“Received COVID-19 Vaccine during January. Pfizer, two doses in my left arm. The first dose was uneventful. Pain in my arm occurred about 6 hours after the shot, that lasted the entire three weeks until my second shot.
The second shot caused more common reactions. Again, pain in my arm, I received... See Morethe second dose 1/12/21 in the same arm, the pain is more of a joint pain, I have noticed a reduction in range of motion for that arm, and lack of strenght. It is still lingering as of 1/21/21. 12 hours later I had a fever of 103 and felt strong flu like symptoms. Body Aches, headache, and exhaustion. That lasted about 24 hours. Currently the only effect I'm still experiencing is arm pain. See Less
Reported By SafelyHQ.com User

January 21, 2021 8:01 PM

“I received the 1st dose of the moderna vaccine on December 31st. I felt absolutely nothing when I was given the shot at 10:30 A.M. The nurse who administered it did an excellent job. Later the same night (around 8-9 PM), I experienced injection site soreness which lasted for approximately 2 days... See Morebefore the soreness completely went away. Although the injection site was sore, I had no stiffness, no difficulty raising my arm or doing ANY activities, no redness, no swelling, no other issues.
Awaiting my 2nd dose.
See Less
Reported By SafelyHQ.com User

January 21, 2021 7:12 PM

“I received my first dosage of the Moderna vaccine on yesterday. Last night I started to have arm soreness, minor pain. Other than that, so far so good. No fever, no headache, no allergic reaction. All of us they were vaccinated were observed for 15 minutes after the injection to make sure we didn’t... See Morehave an acute allergic reaction. See Less
Reported By SafelyHQ.com User

January 21, 2021 7:07 PM

“I saw an ad for a blackcass hand held chainsaw. What arrived was only a chain. Never received anything else See Less
Reported By SafelyHQ.com User

Recent Interesting Reports

January 12, 2021 2:00 PM

“Company name: Midwestern Pet Foods Inc.
Brand name: Sportmix, Nunn Better, ProPac, and Others
Product recalled: Dog and Cat Pet Food
Reason of the recall: Aflatoxin Levels Exceed Acceptable Levels
FDA Recall date: January 11, 2021
Recall details: Company Announcement Midwestern Pet Foods, Inc.,... See Moreof Evansville, IN is expanding its December 30, 2020 voluntary recall of certain dog and cat food products produced in our Chickasha Operations Facility to include all dog and cat pet food products made with corn products because those products may contain aflatoxin levels which exceed acceptable limits. Products were distributed nationally to online distributors and retail stores nationwide. Midwestern Pet Foods is expanding its voluntary recall out of an abundance of caution to help protect the health and safety of pets. The products recalled cover all that expire on or before July 9, 2022, depicted as “07/09/22” in the date code on the product, as discussed below. Products with expiration dates after 07/09/22 are not included in the recall. Aflatoxin is a toxin produced by the mold Aspergillus flavus, which can grow on corn and other grains used as ingredients in pet food. At high levels, aflatoxin can cause illness and death in pets. There have been reports of illnesses and deaths in dogs associated with certain lots of products. No human illnesses have been reported. Out of an abundance of caution, we have expanded this recall to cover all corn products containing pet foods with expiration dates prior to 07/09/22. If your pet shows signs of aflatoxin poisoning including sluggishness, loss of appetite, vomiting jaundice (yellowish tint to the eyes, gums, or skin due to liver damage), and/or diarrhea, contact a veterinarian immediately. Provide a full diet history to your veterinarian. It may be helpful to take a picture of the pet food label, including the lot number and best buy date. Lot code information may be found on the back of bag and will appear in a three‐line code, with the top line in format “EXP 03/03/22/05/L#/B###/HH:MM”.

As explained above, this recall covers ONLY product manufactured at Midwestern Pet Food’s Chickasha, Oklahoma facility. Note that the unique Chickasha Facility identifier is located in the date code as a“05” and “REG. OK‐PFO‐0005” at the end of the date code.

In addition, the only Midwestern Pet Foods facility that produces product bearing a three‐line date code is our Chickasha Facility (See first image below).

Retailers and distributors should immediately pull recalled lots from their inventory and shelves. Do not sell or donate the recalled products. Retailers are encouraged to contact consumers who have purchased the recalled products, if you have the means to do so (frequent buyer cards, etc.). Pet parents: do not feed the recalled products to your pets or any other animals. Destroy the food in a way that children, pets and wildlife cannot access them. Wash and sanitize pet food bowls, cups, and storage containers. Always ensure you wash and sanitize hands after handling recalled food or any utensils which have contacted recalled food. Contact Midwestern Pet Foods Consumer Affairs at 800‐474‐4163, ext. 455 from 7AM to 4PM Central Time, Monday through Friday, or by email at info@midwesternpetfoods.com for additional information. This voluntary recall is being conducted in cooperation with the U.S. Food and Drug Administration. All other Midwestern Pet Foods products are unaffected by this recall action. Recalled products are as follows, with lot codes found in Expanded Recall Lot Numbers:

Pro Pac Adult Mini Chunk
Pro Pac Performance Puppy
Splash Fat Cat 32%
Nunn Better Maintenance
Sportstrail 50
Sportmix Original Cat 15
Sportmix Original Cat 31
Sportmix Maintenance 44
Sportmix Maintenance 50
Sportmix High Protein 50
Sportmix Energy Plus 44
Sportmix Energy Plus 50
Sportmix Stamina 44
Sportmix Stamina 50
Sportmix Bite Size 40
Sportmix Bite Size 44
Sportmix High Energy 44
Sportmix High Energy 50
Sportmix Premium Puppy 16.5
Sportmix Premium Puppy 33

Check the full recall details on fda.gov

Source: FDA
See Less
Reported By SafelyHQ.com User

December 30, 2020 10:00 PM

“Company name: Sportmix
Brand name: Sportmix
Product recalled: Dog and Cat Food
Reason of the recall: Elevated levels of aflatoxin
FDA Recall date: December 30, 2020
Recall details: Midwestern Pet Foods, Inc., of Evansville, IN is issuing a voluntary recall of the below-listed dog and cat food p... See Moreroducts due to tests indicating levels of Aflatoxin that exceed acceptable limits. Products were distributed nationally to online distributors and retail stores. Aflatoxin is a toxin produced by the mold Aspergillus flavus, which can grow on corn and other grains used as ingredients in pet food. At high levels, aflatoxin can cause illness and death in pets.

There have been reports of illnesses and deaths in dogs associated with the below listed lots of Sportmix High Energy. No cat or human illnesses have been reported. If your pet shows signs of aflatoxin poisoning including sluggishness, loss of appetite, vomiting jaundice (yellowish tint to the eyes, gums, or skin due to liver damage), and/or diarrhea, contact a veterinarian immediately. Provide a full diet history to your veterinarian. It may be helpful to take a picture of the pet food label, including the lot number. Lot code information may be found on the back of the bag and will appear in a three-line code, with the top line in the format “EXP 03/03/22/05/L#/B###/HH:MM” as follows (see below in pictures section).

Retailers and distributors should immediately pull recalled lots from their inventory and shelves. Do not sell or donate the recalled products. Retailers are encouraged to contact consumers who have purchased the recalled products if you have the means to do so (frequent buyer cards, etc.).

Pet parents: do not feed the recalled products to your pets or any other animals. Destroy the products in a way that children, pets, and wildlife cannot access them. Wash and sanitize pet food bowls, cups, and storage containers. Contact Midwestern Pet Foods Consumer Affairs at 800-474-4163, ext. 455 from 7AM to 4PM Central Time, Monday through Friday, or by email at info@midwesternpetfoods.com for additional information. This is a voluntary recall conducted in cooperation with the U.S. Food and Drug Administration.

Recalled lot codes are as follows:

- 50# Sportmix Energy Plus Lots Exp 03/02/22/05/L2, 03/02/22/05/L3, 03/03/22/05/L2
- 44# Sportmix Energy Plus Lots 03/02/22/05/L3
- 50# Sportmix Premium High Energy Lots 03/03/22/05/L3
- 44# Sportmix Premium High Energy Lots 03/03/22/05/L3
- 31# Sportmix Original Cat Lots 03/03/22/05/L3
- 15# Sportmix Original Cat Lots 03/03/22/05/L2, 03/03/22/05/L3

Products may be identified as follows (see pictures below).

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

December 31, 2020 11:24 AM

“Responding to an add on facebook I ordered and paid for a battery powered chainsaw on Dec. 13. I then received a confirmation email. On Dec. 30 I received an envelope the size of a cigarette pack containing a manual chainsaw. Where are the fact checkers when you need them? See Less
Reported By SafelyHQ.com User

December 28, 2020 8:00 PM

“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: December 28, 2020
Recall details: Schaumburg, Illinois, Sunstar Americas, I... See Morenc. (SAI) is voluntarily recalling Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% products bearing an expiration date from 12/31/2020 – 9/30/2022 to the consumer level. This product may be contaminated with the bacteria Burkholderia lata. This is an expansion of the recall initially announced on October 27, 2020. 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, 29 adverse events have been reported to SAI related to this recall. Affected patients tested positive for Burkholderia lata infections, typically found in sputum cultures while under treatment for other serious medical conditions. Use of the contaminated product on patients with pre-existing respiratory conditions, including those infected with Covid-19, is particularly unsafe.

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 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 follow below:

-Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% Size/ Form: 16 fl.oz. Amber Bottles. NDC #: 052376-021-02. Product Code: 1789P. Lots Recalled: ALL LOTS with expiration date from Dec. 31, 2020 through Sep. 30, 2022

- Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% Size/ Form: 4 fl.oz. Amber Bottles NDC #: 052376-021-04. Product Code: 1788P. Lots Recalled: ALL LOTS with expiration date from Dec. 31, 2020 through Sep. 30, 2022.

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 Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178. Sunstar is committed to delivering safe, fully compliant products of the highest quality and is taking necessary steps to prevent future occurrence of this issue. 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

December 23, 2020 10:00 PM

“Company name: Shane Erickson, Inc. DBA Innovative Marketing Consultants
Brand name: IMC
Product recalled: Wash-Free Hand Sanitizer
Reason of the recall: Undeclared Methanol
FDA Recall date: December 23, 2020
Recall details: Shane Erickson, Inc. is voluntarily recalling lot 2020/05/11 and MFG:... See More2020/05/10 L/N: 20200510-3 of imc Wash-Free Hand Sanitizer 50 ml, 100 ml, 300 ml and Wash Free Hand Sanitizer 300 ml lot 2020/05/11 and Thrifty White Pharmacy Wash-Free Hand Sanitizer 300 ml lot 2020/05/11 listed in the table below to the consumer level. The products are being recalled due to the potential presence of methanol (wood alcohol).

Risk Statement: Substantial methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death. Although all persons using these products on their hands are at risk, young children who accidentally ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk for methanol poisoning. To date, Shane Erickson, Inc. has not received any reports of adverse events related to the product(s) of this recall. Recalled Products:

- IMC Wash-Free Hand Sanitizer 50 ml, 1.7 oz (8 19845 00597 8). Lot: 43962. Expiration date: 45056
- IMC Wash-Free Hand Sanitizer 100 ml, 3.4 oz (8 19845 00598 5). Lot: MFG: 2020/05/10 L/N: 20200510-3. Expiration date: N/A
- IMC Wash-Free Hand Sanitizer | Wash-Free Hand Sanitizer | Thrifty White Pharmacy Wash-Free Hand Sanitizer 300 ml, 10.14 oz (8 19845 00599 2). Lot: 43962. Expiration date: 45056

The product is used as a hand sanitizer for handwashing to decrease bacteria on the skin when soap and water are not available. All products are packaged in a plastic bottle. The 50 ml are in a HDPE opaque white bottle with a blue cap, the 100 ml is in a clear PET bottle with a clear cap and the 300 ml are in a clear PET bottle with a black pump. The product can be identified by checking the product size, UPC details, lot number and expiration date on the bottle containing the product. The product can also be identified by this information on the back label: Made in China, Distributed by IMC 4284 Shoreline Dr, Spring Park, MN 55384, YUEWEIXIAOZHENGZI (2020) - 04 - No. 0023.

Some of the product has custom front labels (see examples below) the back label on the custom labels have the same identification information as previously mentioned above. The hand sanitizer was distributed Nationwide in the USA to wholesale and retail customers.

Shane Erickson, Inc. is notifying its distributors and customers by mail/email and is arranging for the return of all recalled products. Consumer, distributors, and retailers that have product, which is being recalled, should stop use or distribution and return to place of purchase. Consumers with questions regarding this recall can contact Shane Erickson, Inc. by phone at 952.252.1254 [Call: 952.252.1254] or email sales@imcsuccess.com Monday through Friday from 8:00 am to 5:00 pm Central Time Zone.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

January 17, 2021 11:59 PM

“The FSA announced the recall of several dog food products by Mars Petcare UK because they may contain high levels of vitamin D which exceed the maximum permitted intake.

FSA advises pet owners that if they have bought any of the following dog food products, you should stop feeding them to your do... See Moreg and contact Mars Petcare Customer Service at 0800 013 3131. If you have concerns that your pet may be showing symptoms of illness after eating one of the affected products, please contact a veterinarian.

- CHAPPIE Complete Chicken & Wholegrain Dry Dog Food (3kg). Batch code: 045F9MIN05. Best before: 44692
- PEDIGREE Mixer Adult Dry Dog Original (3kg). Batch code: 046E9MIN05 | 046F9MIN05 | 048A9MIN05. Best before: 12 February 2022 | 20 February 2022 | 22 February 2022
- PEDIGREE Mixer Adult Dry Dog Food Original (10kg). Batch code: 046E9MIN08 | 047C9MIN08. Best before: 12 February 2022 | 17 February 2022
- PEDIGREE Adult Complete Dry Dog Food with Chicken & Vegetables (12kg). Batch code: 046C9MIN08 | 046D9MIN08 | 046E9MIN08. Best before: 10 February 2022 | 11 February 2022 | 12 February 2022
- PEDIGREE Adult Complete Dry Dog Food with Chicken & Vegetables (2.6kg). Batch code: 045F9MIN05 | 047A9MIN05. Best before: 06 February 2022 | 15 February 2022

High levels of vitamin D fed to a pet over a short period (weeks/months) should not cause undue concern. Over a longer period of feeding, ingestion of elevated levels can lead to potential dog health issues. Vitamin D, when consumed at very high levels, can lead to serious health issues in dogs including renal dysfunction.

Check the full recall details on the FSA website food.gov.uk

Source: FSA
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Reported By SafelyHQ.com User

January 14, 2021 8:47 PM

“The owner refused to wipe down the countertop or the card swipe after me requesting him to do so after several people using it. I want everyone to refrain from going to this station since he does nothing to protect people during covid 19 See Less
Reported By SafelyHQ.com User

January 4, 2021 7:46 PM

“I ordered a hand held chain saw on Dec 12th 2020. I was v
Charged $40.89 .
What did come in the mail
Was a extra chain, but no saw See Less
Reported By SafelyHQ.com User

January 8, 2021 6:01 PM

“Company name: Fresenius Kabi USA
Brand name: Fresenius Kabi
Product recalled: Ketorolac Tromethamine Injection, USP, 30 mg/mL
Reason of the recall: Presence of particulate matter
FDA Recall date: January 08, 2021
Recall details: Fresenius Kabi USA is voluntarily recalling a single lot of Ketoro... See Morelac Tromethamine Injection, USP, 30 mg/mL, 1 mL fill in a 2 mL amber vial to the user level due to the presence of particulate matter. Particulate matter was found in reserve sample vials. No adverse event reports have been received for the recalled lot, which was produced and sold in 2019.

Administration of products containing particulate matter could obstruct blood vessels and result in local irritation of blood vessels, swelling at the site of injection, a mass of tissue that could become inflamed and infected, blood clots traveling to the lung, scarring of the lung tissues, and allergic reactions that could lead to life-threatening consequences.

Ketorolac Tromethamine, a nonsteroidal anti-inflammatory drug, is indicated for the short-term (up to 5 days in adults) management of moderately severe acute pain that requires analgesia at the opioid level. The total combined duration of use of oral Ketorolac Tromethamine and Ketorolac Tromethamine Injection should not exceed 5 days. Listed below is a table of the recalled lot distributed nationwide in the United States to wholesalers, distributors, hospitals, and pharmacies between March 28, 2019 and September 3, 2019.

Product Name/Product size: Ketorolac Tromethamine Injection, USP, 30mg / mL, 1 mL fill in a 2 mL amber vial
NDC Number: 63323-162-01
Product Code: 160201
Batch Number: 6121083
Expiration Date: 02/2021
First Ship Date: 03/28/2019
Last Ship Date: 09/03/2019

Fresenius Kabi is notifying its distributors and customers by letter and asking customers and distributors 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 the affected lot, and to return the product to Fresenius Kabi.

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

January 21, 2021 7:07 PM

“I saw an ad for a blackcass hand held chainsaw. What arrived was only a chain. Never received anything else See Less
Reported By SafelyHQ.com User