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Costa Mesa, California, United States
Updated: April 1, 2021 12:00 PM
Covid-19 OSHA Complaint, Turner's Pub 33, 1562 Newport Boulevard, COSTA MESA, CA, 92627, USA
Turner's Pub 33, 1562 Newport Boulevard, COSTA MESA, CA, 92627, USA
April 1, 2021 12:00 PM
“T8 CCR § 3203(a)(4)(C) - Bar opened for business, and employees are concerned with exposure to Covid-19.
Alleged Hazards: 1, Employees Exposed: 5
Source: Osha.gov | Receipt Date: 2020-07-06 See Less”
Helpful
Johnson & Johnson COVID-19 Vaccine - Headache, fever, nausea, body aches, Costa Mesa, CA, USA
Symptoms: Nausea
Fever
Headache
Body Ache
Costa Mesa, CA, USA
March 16, 2021 12:52 PM
“Received the single shot Johnson & Johnson vaccine at 10:30 AM Saturday, 3/13/2021. At 5:00 PM the headache began. 6:00 PM I began experiencing chills. Checked temperature and had a fever of 101.4. Took Ibuprofen as this continued through the night. The next morning I had strong nausea but it manage... See Mored to subside after a few hours. Headache, fever, body aches, and fatigue continued through Sunday. Then on Monday, about 48 hours after the shot, symptoms began to subside. Symptoms appear to have completely gone away by 5pm Monday, so 48 hours after onset of symptoms.
Plan for a couple days of downtime when you get this vaccine. My wife who never gets sick got the same shot and had most of the same symptoms, though to a lesser degree. I would still rather build immunity this way than get full blown COVID-19. If the vaccine did this to me, COVID would have done much worse. I wish you all the best and hope you experience less of the symptoms than I did. See Less”
Helpful
Covid-19 OSHA Complaint, Chanel Boutique South Coast Plaza, 3333 Bristol Street, COSTA MESA, CA, 92626, USA
Chanel Boutique South Coast Plaza, 3333 Bristol Street, COSTA MESA, CA, 92626, USA
January 21, 2021 12:00 PM
“1. T8 CCR § 3205(c)(6) - Employer not enforcing physical distancing protocol in the store. No signage. 2. T8 CCR § 3225(a)(1) - Exit doors blocked with box boxes of merchandise.
Alleged Hazards: 2, Employees Exposed: 50
Source: Osha.gov | Receipt Date: 2020-11-24 See Less”
Helpful
Covid-19 OSHA Complaint, Mastro's Steakhouse, 633 Anton Blvd, COSTA MESA, CA, 92626, USA
Mastro's Steakhouse, 633 Anton Blvd, COSTA MESA, CA, 92626, USA
January 14, 2021 12:00 PM
“Employer has been violating the outdoor dining mandate. Over the holiday weekend and sporadically since has continued to provide indoor seating to guests. There are 3 to 4 tables that are consistently used for such indoor seating with one of the tables being used for groups of 10 or more. I don't al... See Moreways feel safe at work and I have two small children at home, one that has respiratory issues. My employer has received a violation previously. I don't feel that it is the desire of my General Manager to continue such practice but I feel his job is being threatened by the owner and in such times losing a job would be devastating. I don't want anyone to get in trouble but the safety of my family, myself, and all people is more important.
Alleged Hazards: 1, Employees Exposed: 1
Source: Osha.gov | Receipt Date: 2020-12-04 See Less”
Helpful
Covid-19 OSHA Complaint, AutoNation Honda Costa Mesa Service Center, 2888 Harbor Boulevard, COSTA MESA, CA, 92626, USA
AutoNation Honda Costa Mesa Service Center, 2888 Harbor Boulevard, COSTA MESA, CA, 92626, USA
January 14, 2021 12:00 PM
“T8 CCR § 3203(a)(2) - Face coverings order not enforced in the workplace.
Alleged Hazards: 1, Employees Exposed: 5
Source: Osha.gov | Receipt Date: 2020-07-16 See Less”
Helpful
Covid-19 OSHA Complaint, Pure Harmony Massage Spa, 1755 Orange Avenue, COSTA MESA, CA, 92627, USA
Pure Harmony Massage Spa, 1755 Orange Avenue, COSTA MESA, CA, 92627, USA
January 14, 2021 12:00 PM
“T8 CCR § 3203(a)(4)(C) - Employer does not have a plan to address the hazard of Covid-19, such as sanitizing, disinfecting, providing cleaning products, taking temperatures.
Alleged Hazards: 1, Employees Exposed: 5
Source: Osha.gov | Receipt Date: 2020-06-23 See Less”
Helpful
Covid-19 OSHA Complaint, AutoNation Honda Costa Mesa Service Center, 2888 Harbor Boulevard, COSTA MESA, CA, 92626, USA
AutoNation Honda Costa Mesa Service Center, 2888 Harbor Boulevard, COSTA MESA, CA, 92626, USA
January 14, 2021 12:00 PM
Ҥ3380 - Employer not enforcing use of PPE
Alleged Hazards: 1, Employees Exposed: 1
Source: Osha.gov | Receipt Date: 2020-04-23 See Less”
Helpful
Covid-19 OSHA Complaint, Oak Tree Business Systems, Inc, 485 East 17th Street, COSTA MESA, CA, 92627, USA
Oak Tree Business Systems, Inc, 485 East 17th Street, COSTA MESA, CA, 92627, USA
January 14, 2021 12:00 PM
“1. T8CCR 3203 No communication by the employer regarding Covid 19, No Social Distancing, Not telling employees co-worker tested positive 2. T8CCR 3362 No cleaning supplies
Alleged Hazards: 2, Employees Exposed: 1
Source: Osha.gov | Receipt Date: 2020-04-13 See Less”
Helpful
Covid-19 OSHA Complaint, Ralphs, 380 E 17th St, COSTA MESA, CA, 92627, USA
Ralphs, 380 E 17th St, COSTA MESA, CA, 92627, USA
December 2, 2020 12:00 PM
“Mask order not being enforced.
Alleged Hazards: 1, Employees Exposed: 1
Source: Osha.gov | Receipt Date: 2020-06-29 See Less”
Helpful
Covid-19 OSHA Complaint, Irvine Ranch Market, 2651 Irvine Avenue, Costa Mesa, CA 92627, USA
Irvine Ranch Market, 2651 Irvine Avenue, Costa Mesa, CA 92627, USA
November 25, 2020 12:00 PM
“1. T8 CCR § 3203(a)(4) and (a)(6) - Positive cases of Covid-19 not addressed effectively by Employer. Employees concerned with potential exposure to Covid-19 in the workplace. 2. T8 CCR § 3362 - Employer not sanitizing the workplace after exposure to Covid-19. 3. T8 CCR § 3362 - Rat infestation in t... See Morehe workplace.
Alleged Hazards: 4, Employees Exposed: 8
Source: Osha.gov | Receipt Date: 2020-10-26 See Less”
Helpful
Recent Interesting Reports
March 27, 2021 11:00 PM
“Company name: Midwestern Pet Foods
Brand name: Multiple brands
Product recalled: Dog and Cat Food
Reason of the recall: Potential Salmonella Contamination
FDA Recall date: March 27, 2021
Recall details: Midwestern Pet Foods, Evansville, Indiana is issuing a voluntary recall of specific expirati... See Moreon dates of certain dog and cat food brands including CanineX, Earthborn Holistic, Venture, Unrefined, Sportmix Wholesomes, Pro Pac, Pro Pac Ultimates, Sportstrail, Sportmix and Meridian brands produced at its Monmouth, Illinois Production Facility because they have the potential to be contaminated with Salmonella. A full list of recalled products may be found at the end of this announcement. Salmonella can affect animals eating the products and there is risk to humans from handling contaminated pet products, especially if they have not thoroughly washed their hands after having contact with the products or any surfaces exposed to these products.
Healthy people infected with Salmonella should monitor themselves for some or all of the following symptoms: nausea, vomiting, diarrhea or bloody diarrhea, abdominal cramping and fever. Rarely, Salmonella can result in more serious ailments, including arterial infections, endocarditis, arthritis, muscle pain, eye irritation, and urinary tract symptoms. Consumers exhibiting these signs after having contact with this product should contact their healthcare providers.
Pets with Salmonella infections may be lethargic and have diarrhea or bloody diarrhea, fever, and vomiting. Some pets will have only decreased appetite, fever and abdominal pain. Infected but otherwise healthy pets can be carriers and infect other animals or humans. If your pet has consumed the recalled product and has these symptoms, please contact your veterinarian. No human or pet illnesses have been reported to date.
Products were distributed to retail stores nationwide and to online retailers. Lot code information may be found on the back of the bags with the following format: “EXP AUG/02/22/M1/L# See Example Image Below This recall covers only certain products manufactured at Midwestern Pet Foods Monmouth, Illinois facility. The unique Monmouth Facility identifier is located in the date code as an “M”. The recall was as the result of a routine sampling program by the company which revealed that the finished products may contain the bacteria.
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 that have purchased the recalled products if the means to do so exists. Do not feed the recalled products to 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 your hands after handling recalled food or any utensils that come in contact with recalled food. Contact Midwestern Pet Foods Consumer Affairs at info@midwesternpetfoods.com or 800-474-4163, ext 455 from 8 AM to 5 PM Central Time, Monday through Friday for additional information. This voluntary recall is being conducted in cooperation with the US Food and Drug Administration. All other Midwestern Pet Foods products are unaffected by this recall.
Check the full recall details on fda.gov
Source: FDA See Less”
Doctor Visit: Yes
Diagnosis: Salmonella
Helpful
March 16, 2021 5:00 PM
“Company name: Bravo Packing, Inc.
Brand name: Bravo Packing, Inc.
Product recalled: Pet food: Performance Dog, beef, green tripe, and bone
Reason of the recall: Due to Potential Salmonella and Listeria monocytogenes
FDA Recall date: March 16, 2021
Recall details: Bravo Packing, Inc. of Carneys... See MorePoint, NJ is expanding the previously announced voluntary recall of two pet food products to now include all pet food and bones in all package sizes. During an FDA inspection, samples collected tested positive for Salmonella and Listeria monocytogenes and resulted in a recall due to the potential health risks to humans and pets. Bravo Packing, Inc. is expanding the recall due to potential cross contamination.
No human or animal illnesses related to the identified products have been reported to date. Bravo Packing Inc. generally works with distributors that fill orders to retail stores and to consumers directly nationwide. Consumers with any of the affected products should handle them with caution, discard products in a secure container, and wash hands and surfaces properly. Consumers with questions should contact Bravo Packing, Inc. at 856-299-1044 (Monday – Friday, 9:00 AM-2:00 PM, EST). Recalled Products:
- “Performance Dog” (chub) frozen raw dog food (2 lbs.)
- “Performance Dog” (chub) frozen raw dog food (5 lbs.)
- “Green Tripe” (chub - ground bovine stomach) frozen raw dog food (2 lbs.)
- “Green Tripe” (chub - ground bovine stomach) frozen raw dog food (5 lbs.)
- “Beef” (chub - ground) frozen raw dog food (2 lbs.)
- “Beef” (chub - ground)frozen raw dog food (5 lbs.)
- “Performance Dog” (patties) frozen raw dog food (unknown)
- “Tripe” (patties ¼ lbs.) frozen raw dog food (unknown)
- Bones (smoked) 14 varieties (unknown)
Salmonella can cause illness in pets eating the products, as well as people who handle contaminated pet food products, especially if they have not thoroughly washed their hands after having contact with the products, infected pets, or any surfaces exposed to these products. People infected with Salmonella should monitor themselves for some or all of the following symptoms: nausea, vomiting, diarrhea or bloody diarrhea, abdominal cramping, and fever. Rarely, Salmonella can result in more serious ailments, including arterial infections, endocarditis (an infection of the heart muscle), arthritis, muscle pain, eye irritation, and urinary tract symptoms. People who have these symptoms after having contact with the products identified in this recall or with a pet that has eaten these products should contact their healthcare providers.
A pet with a Salmonella infection may be lethargic and have diarrhea or bloody diarrhea, fever, and vomiting. Some pets will have decreased appetite, fever, and abdominal pain. If your pet has consumed the recalled products and has these symptoms, please contact your veterinarian. Pets exposed to contaminated food can be infected without showing symptoms. Infected pets, including those without symptoms, can also shed Salmonella through their feces and saliva, spreading pathogens into the home environment and to humans and other animals nearby.
Listeria monocytogenes is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain, and diarrhea, Listeria monocytogenes infection can cause miscarriages and stillbirths among pregnant women.
Check the full recall details on fda.gov
Source: FDA See Less”
Helpful
1 person found this review helpful
March 30, 2021 10:00 AM
“Company name: Bit & Bet LLC
Brand name: Thumbs Up 7
Product recalled: Blue 69K Dietary Supplement for male sexual enhancement
Reason of the recall: Undeclared Sildenafil and Tadalafil
FDA Recall date: March 30, 2021
Recall details: Bit & Bet LLC is voluntarily recalling all lots of Thumbs Up 7... See MoreBlue 69K capsules to consumer level. FDA analysis has found the product to contain undeclared sildenafil and tadalafil. Sildenafil and tadalafil are ingredients known as phosphodiesterase (PDE-5) inhibitors found in FDA approved products for the treatment of male erectile dysfunction.
The presence of sildenafil and tadalafil in Thumbs Up 7 Blue 69K capsules make them unapproved new drugs for which the safety and efficacy have not been established and, therefore subject to recall. Consumers with underlying medical issues who take Thumbs Up 7 Blue 69K capsules with undeclared sildenafil and tadalafil may experience serious health risks. For example, PDE-5 inhibitors may interact with nitrates found in some prescription drugs (such as nitroglycerin) lowering blood pressure to dangerous levels that may be life-threatening. Consumers with diabetes, high blood pressure, or heart disease often take nitrates.
To date, Bit & Bet has not received any reports of adverse events related to this recall. To date, Bit & Bet has not received any reports of adverse events related to this recall This tainted product is marketed as a dietary supplement for male sexual enhancement and is packaged in blister foil sheets in a box labeled with UPC 6 17135 89467 3. Each box contains 10 capsules. The affected lot numbers of Thumbs Up 7 Blue 69K includes all lots. Thumbs Up 7 Blue 69K was distributed via internet and fulfilled by amazon at www.amazon.com nationwide in the USA.
On December 17, 2020, FDA issued a press release that warned consumers to avoid certain products found on Amazon, e Bay and other retailers due to hidden and potentially dangerous drug ingredients. It also encouraged online marketplaces to ensure these products are not sold on their platforms. Bit & Bet LLC is notifying its customers by this press announcement and via email of this recall. Consumers that have Thumbs up 7 Blue 69K, which is being recalled should stop using and descard them.
Consumers with questions regarding this recall can contact Bit & Bet LLC by phone at (201) 208-2836 Monday to Friday from 9AM to 5PM or e-mail thumbsup7blue@gmail.com. For more information, please visit www.thumbsup7blue.com. Consumers should contact their physicians or healthcare provider if they have experienced any problems that may be related to takin 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. 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”
Helpful
March 25, 2021 11:00 AM
“Company name: Zydus Pharmaceuticals Inc.
Brand name: Zydus Pharmaceuticals
Product recalled: Acyclovir Sodium Injection, 50 mg/mL, 10 mL and 20 mL vials
Reason of the recall: Due to Crystalization
FDA Recall date: March 25, 2021
Recall details: Pennington, NJ, Zydus Pharmaceuticals (USA) Inc. i... See Mores voluntarily recalling four lots of Acyclovir Sodium Injection, 50 mg/mL, 10 mL and 20 mL vials, to the Hospital/User level after receiving several complaints of crystallization in vials.
Administration of crystalized Acyclovir Sodium Injection, 50 mg/mL has a potential of life-threatening adverse consequences including injection site inflammation of a vein and local reactions, damage and/or obstruction of blood vessels, which could induce clots, particularly in the lungs, the passage of the particulate matter into the bloodstream may lead to clots resulting in stroke, heart attack, decreased liver or kidney function or death of tissues or cells.
To date, Zydus Pharmaceuticals (USA) Inc. has not received any reports of adverse events related to this product recall. Acyclovir Sodium Injection, 50 mg/mL is indicated for the treatment of herpes simplex infections in immunocompromised patients, severe initial clinical episodes of herpes genitalis in immuno-competent patients, herpes simplex encephalitis, neonatal herpes simplex virus infection and varicella-zoster (shingles) infections in immunocompromised patients.
The product is packaged in single-dose glass vials and was distributed nationwide in the USA to Cardinal Health, Amerisourcebergen Drug Corporation and Morris & Dickson Company LLC. The affected Acyclovir Sodium Injection, 50 mg/mL lots include the following lot numbers and expiration dates:
- Acyclovir Sodium Injection, 50 mg/mL, 20 mL. Carton NDC Number: 68382-049-10. Vial NDC Number: 68382-049-01. Lot Number: L000155. Expiry Date: Dec 2021. Pack Size: 10x20 mL, Single-Dose Vial pack.
- Acyclovir Sodium Injection, 50 mg/mL, 20 mL. Carton NDC Number: 68382-049-10. Vial NDC Number: 68382-049-01. Lot Number: L000156. Expiry Date: Jan 2022. Pack Size: 10x20 mL, Single-Dose Vial pack.
- Acyclovir Sodium Injection 50 mg/mL, 10 mL. Carton NDC Number: 68382-048-10. Vial NDC Number: 68382-048-01. Lot Number: L000126. Expiry Date: Dec 2021. Pack Size: 10x10 mL, Single-Dose Vial pack.
- Acyclovir Sodium Injection 50 mg/mL, 10 mL. Carton NDC Number: 68382-048-10. Vial NDC Number: 68382-048-01. Lot Number: L000127. Expiry Date: Dec 2021. Pack Size: 10x10 mL, Single-Dose Vial pack.
Zydus Pharmaceuticals (USA) Inc. has notified its distributors and customers by email and FedEx overnight courier service and is arranging for the return of all recalled Acyclovir Sodium Injection, 50 mg/mL lots. Hospitals that have the product which is being recalled should stop using it immediately and call our recall coordinating center at 1-855-671-5023 [Call: 1-855-671-5023] Monday – Friday (excluding holidays), 9:00 am to 5:00 pm EST.
Consumers with questions regarding this recall can contact Zydus Pharmaceuticals (USA) Inc. by phone: 1-877-993-8779 [Call: 1-877-993-8779] or by email: medicalaffairs@zydususa.com Monday – Friday (excluding holidays), 9:00 am to 5:00 pm EST. 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”
Helpful
1 person found this review helpful
April 6, 2021 9:13 PM
“Got my first shot yesterday afternoon at Walgreens. Felt fine most of the evening. Woke up at 1am and my left arm (I had the shot in my left arm) was numb along with the left side of my face. I started to panic thinking great it’s a stroke but I read about temporary Bell’s palsy and calmed down and... See Morewent to sleep. Woke up at 8:30. My arm was very sore which got worse as the day went on, I was very fatigued and had a low fever which Tylenol got rid of. Aches and pains came and went all day. My top lip on my left side of my mouth is still numb and parts of my face feels numb still but I look fine and feel fine otherwise. 30 hours later i would say the worst is the arm pain, I can’t really use my arm. I suggest getting it in your non dominant arm/hand which was suggested to me. Overall the numbness was scary but I think the vaccine is worth it. See Less”
Helpful
1 person found this review helpful
March 17, 2021 11:00 AM
“Company name: PNHC, LLC d/b/a Heal the World
Brand name: Heal the World
Product recalled: Hand Sanitizer
Reason of the recall: Because they resemble water bottles; risk of ingestion
FDA Recall date: March 17, 2021
Recall details: Raleigh, North Carolina, PNHC, LLC, d/b/a Heal the World, is vol... See Moreuntarily recalling all lots of Heal the World hand sanitizer packaged in 9.6 fl. oz containers to the consumer level. The products are being recalled because they resemble 9.6ounce water bottles. The recall does not affect any other Hand Sanitizer products from PNHC, LLC and/or Heal the World.
- Heal the World Hand Sanitizer (9.6 FL. OZ (285 mL)). NDC: 73333-285-01. Lot Nos. SAA21, SAA24, SAA27, SAA22, SAA23, SAA29, SAA26, SAA28, SAA25, SAA32, SAA55, SAA56, SAA44, SAA60.
To date, PNHC, LLC, d/b/a Heal the World has received no reports of adverse reactions and no complaints have been received. 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.
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 9.6 ounce plastic bottles. The product can be identified by the bottle’s label pictured below. Product was distributed to selected retailers in the United States.
PNHC, LLC has provided notification to its distributors and retailers. Distributors and retailers that have product which is being recalled should stop distribution. While the product is not available for purchase and has not been available for several months, if a consumer has product which is being recalled he or she is advised to contact the entity who sold the product to consumer for return.
Consumers with questions regarding this recall can contact PNHC, LLC at 813-434-0741 from 9:00 am- 5:00 pm EST, Monday through Friday. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this product.
Check the full recall details on fda.gov
Source: FDA See Less”
Helpful
Pfizer First Dose Vaccine, Parkland Hospital, Harry Hines Boulevard, Dallas, TX, USA
Symptoms: Headache
Fatigue
Soreness
Parkland Hospital, Harry Hines Boulevard, Dallas, TX, USA
April 2, 2021 7:33 PM
“The vaccine process went relatively smooth. Waited the recommended 15 minutes for any allergic reactions. Had none. My side effects have been mild. Headache, run down feeling, head fogginess, sore arm from where the vaccine was injected, alittle fatigued, and have noticed my heart rate being alittle... See Moretoo high for comfort. See Less”
Helpful
1 person found this review helpful
Johnson&Johnson vaccine, Kansas City, KS, USA
Kansas City, KS, USA
April 9, 2021 3:15 PM
“I got the j&j vac at 1:00pm its been 1 hour so far only a slight tingling on vaccination spot other than that nothing big hoping for the best See Less”
Helpful
1 person found this review helpful
March 29, 2021 9:50 PM
“My wife and I wanted to get the CoV2 vaccine but had significant concerns about the messenger RNA versions.
Anyway, we got the J&J vaccine, and we are satisfied with it.
However, some things need to be stated. My wife had a 103.3-degree fever the night of her shot. I didn't feel great, but the... See Moreaftereffects took longer to present themselves. While I had a slight fever, my response presented itself as bruises that itched terribly.
We are two weeks out from the vaccine, and things are going back to normal. My wife and I had to build up our stamina from the day of the shot and now (two weeks and four days ago).
Overall, we still feel that the J&J jab was the best vaccine for us. Even though this vaccine's efficacy looks less than the others, it is quite comparable if you look at the places it was tested and when it was tested.
We would highly recommend this vaccine to all who would prefer a more conventional vaccine. See Less”
Helpful
March 25, 2021 9:01 AM
“Company name: Sanit Technologies LLC d/b/a Durisan
Brand name: Durisan
Product recalled: Antimicrobial Hand Sanitizer
Reason of the recall: Due to microbial contamination
FDA Recall date: March 24, 2021
Recall details: Sanit Technologies LLC d/b/a Durisan announces a voluntary recall of the lot... See Mores listed in the table below of Durisan Antimicrobial Hand Sanitizer, Non-Alcohol products in various sizes listed. The products are being recalled due to microbial contamination. Specifically, out of specification results for bacterial count for Burkholderia cepacia complex and Ralstonia pickettii. The issue was discovered during a routine audit focused on production scale-up during the height of the pandemic.
Check the link below for the full list of Durisan Antimicrobial Solutions Hand Sanitizer Sizes and Lot Numbers. To date, no reports of adverse reactions or customer complaints have been reported related to this recall.
The product was packaged in sizes ranging from 18mL credit cards, to bottles sized in 118, 236, 300 and 550 mL and 1000mL wall mounted dispenser refills. Pictures are available in the attached related file.
Use of a hand sanitizer contaminated with Burkholderia cepacia complex and Ralstonia pickettii, can range from no reaction to serious infections in a person with a hand wound or scrapes because the bacteria could enter the bloodstream, especially in patients with compromised immune systems. Health care professionals who use this contaminated hand sanitizer and tend to an at-risk patient, such as one with cystic fibrosis, could lead to adverse events ranging from a localized infection to lung or bloodstream infections, which could require patient hospitalization.
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. The product can be identified by examples of the product labels below. The product was manufactured from Feb. 1, 2020 until June 30, 2020, and distributed to selected retailers nationwide in the United States.
Durisan has provided written notification to its distributors and retailers and is alerting customers via this voluntary recall. Consumers that have the product which is being recalled are advised to destroy it immediately.
Consumers with questions regarding this recall can contact Durisan at 941-351-9114 [Call: 941-351-9114] , 8:30 am - 4:30 pm Eastern time, Monday through Friday or by e-mail at customerservice@durisan.com. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this drug product.
Check the full recall details on fda.gov
Source: FDA See Less”
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1 person found this review helpful