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Updated: June 18, 2020 11:00 PM
June 18, 2020 11:00 PM
“Company name: GSK Consumer Healthcare
Brand name: Robitussin
Product recalled: Cough and cold products
Reason of the recall: Incorrect dosing cups
FDA Recall date: June 18, 2020
Recall details: GSK Consumer Healthcare is voluntarily recalling to the retail level two lots (listed below) of Ch... ildren's Robitussin® Honey Cough and Chest Congestion DM and one lot of Children's Dimetapp® Cold and Cough, due to the inclusion of incorrect dosing cups. During the review of the packaging documents for these products, GSK discovered that the dosing cups for the Children's Robitussin® Honey product are missing the 5 mL and 10 mL graduations, while the dosing cups for the Children's Dimetapp® product are missing the 10 mL graduation. The dosing cups packaged with both products only have the 20 mL graduation.
There is a potential risk of accidental overdose if caregivers dispensing the syrup do not notice the discrepancies between the graduations printed on the dosing cups and the indicated amounts to be administered (as directed in the instructions for use). Children's Robitussin Honey Cough & Chest Congestion DM contains 10 mg dextromethorphan HBr USP and guaifenesin USP 100 mg per 10 mL, and is labeled for children 4 and older, as well as adults. Children's Dimetapp Cold & Cough contains 2 mg brompheniramine maleate USP, 10 mg dextromethorphan HBr USP, and 5 mg phenylephrine HCl USP per 10 mL, and is labeled for children 6 and older, as well as adults.
Symptoms of overdose of either product may include any of the following: impaired coordination; brain stimulation causing increase in energy, elevation in blood pressure, heart rate, and respiration; a lack of energy and enthusiasm; severe dizziness or drowsiness; slow heart rate; fainting; psychotic behaviour; restlessness; seizure; decreased respiration; nausea; vomiting; constipation; diarrhea; abdominal pain; visual and hearing hallucinations; urinary retention.
As of the date of the recall announcement, GSK Consumer Healthcare has not received any adverse events related to these products or consumer complaints regarding the incorrect dosing cups supplied with the product. The recall is limited to the three lots listed below:
Children's Robitussin® Honey Cough and Chest Congestion DM (4oz)
Lots: 02177 (Exp. Jan. 2022) / 02178 (Exp. Jan. 2022)
Children's Dimetapp® Cold and Cough (8oz)
Lot: CL8292 (Exp. Sep. 2021)
These lots were distributed nationwide between February 5, 2020 and June 3, 2020 within the United States. GSK Consumer Healthcare has notified wholesalers, distributors and retailers to arrange for return of any recalled product. Wholesalers, distributors and retailers with an existing inventory of the lots being recalled should stop distribution and quarantine these lots immediately.
Wholesalers, distributors and retailers that have further distributed the recalled product should notify any accounts or additional locations which may have received the recalled product from them. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this 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. In December 2018, GlaxoSmithKline plc reached an agreement with Pfizer, Inc. to combine their consumer health businesses into a new Joint Venture. August 01, 2019 was the first day of the new GSK Consumer Healthcare Joint Venture. Thus, when identifying impacted product, please be aware the Pfizer company name will still be present on the label.
Check the full recall details on fda.gov
Source: FDA ”
Recent Interesting Reports
St. George, UT, USA
January 7, 2021 7:57 PM
“I purchased the portable carbon steel chain from Blackcass. When going to their site, It looks like you are getting the Chain saw and are advertising it for $29.99 When in reality you are purchasing the chain for $29.99. They do advertise that you are getting the chain and not the chainsaw, but m... ake it look like you are getting the saw. When you look at the ad it is very deceiving. I do realize that I did not pay attention when I pushed the buy button. They do say 100% money back guarantee, but do not honor that when you try to return the item. I keep contacting the company. First they offered me the saw at a discount price. Second they offered me 10% of my money back. Then 12% then 15% twice. They keep saying that not to return the item until they give me the return address. They have not yet sent me the return address. I have a friend that says they wait to send me the return address until it is too late to send it to them because they give you 30 days to return the item. They have not yet sent me the address. I just want to send it back. I have contacted paypal and they say there is nothing they can do. I have contacted yt network technology which is the company that paypal says I purchased the item from. I have only heard from them 1 time and sent them the information that they asked for, but have not heard back. What do I do? Can this company be stopped? ”
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... in 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 email@example.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 ”
Fresenius Kabi USA Ketorolac Tromethamine Injection, USP, 30 mg/mL - recalled due to Presence of particulate matter, USA
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... lac 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 ”
December 30, 2020 9:21 AM
“The FDA is alerting pet owners and veterinary professionals about certain Sportmix pet food products manufactured by Midwestern Pet Foods, Inc. that may contain potentially fatal levels of aflatoxin. As of December 30, 2020, 28 deaths and 8 illnesses in dogs that ate the recalled product have been r... eported. This is an ongoing investigation. Case counts and the scope of this recall may expand as new information becomes available.
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. Pets experiencing aflatoxin poisoning may have symptoms such as sluggishness, loss of appetite, vomiting, jaundice (yellowish tint to the eyes or gums due to liver damage), and/or diarrhea. In severe cases, this toxicity can be fatal. In some cases, pets may suffer liver damage but not show any symptoms.
Pet owners should stop feeding their pets the recalled products listed below and consult their veterinarian, especially if the pet is showing signs of illness. The pet owner should remove the food and make sure no other animals have access to the recalled product. Sanitize pet food bowls, scoops, and storage containers using bleach, rinsing well afterwards with water, and drying thoroughly. There is no evidence to suggest that pet owners who handle products containing aflatoxin are at risk of aflatoxin poisoning.
Midwest Pet Food, Inc. already recalled the following lots of Sportmix pet food products:
- Sportmix Energy Plus, 50 lb. bag. Lots: Exp 03/02/22/05/L2 | Exp 03/02/22/05/L3 | Exp 03/03/22/05/L2
- Sportmix Energy Plus, 44 lb. bag. Lot: Exp 03/02/22/05/L3
- Sportmix Premium High Energy, 50 lb. bag. Lot: Exp 03/03/22/05/L3
- Sportmix Premium High Energy, 44 lb. bag. Lot: Exp 03/03/22/05/L3
- Sportmix Original Cat, 31 lb. bag. Lot: Exp 03/03/22/05/L3
- Sportmix Original Cat, 15 lb. bag. Lots: Exp 03/03/22/05/L2 | Exp 03/03/22/05/L3
Check the full outbreak announcement on fda.gov
Source: FDA ”
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? ”
Mount Pleasant, SC, USA
January 22, 2021 12:40 PM
“Adverse reaction in arm now requires surgery. Orthro surgeon, MRI confirm the damage is from reaction not needle placement. Also, extreme fatigue, had tremors and brain fog. ”
Symptoms: Joint Pain Soreness
San Angelo, TX, USA
January 22, 2021 5:53 PM
“I had my first dose of the Moderna vaccine on January 3. The next day I had arm soreness at the site of the injection but not as bad a my flu shot back in September. The second day I had a little bit of soreness in my joints but was really no big deal. It did not keep me from doing anything I would... normally do. This shows that your body is mounting an immune defense to the virus. Overall, my experience was excellent‼️
This vaccine is a godsend and I would encourage everyone to get vaccinated and DO NOT believe the misinformation about it changing your DNA👎🏻 It is impossible for any VACCINATION to change your DNA.
The mRNA vaccine prompts you own immune system to make it’s own antigen against the virus. This technology is absolutely amazing.
Do your research on mRNA vaccines and it will blow your mind. So exciting for the future.
A lot of effort went in to getting this vaccine along with the Pfizer vaccine out to the American citizens and I feel like it has been politicized to death. I know MANY people who have had both the Pfizer and Moderna vaccines with no issues. If you have concerns about your ability to get the vaccine, talk to your Doctor, PA or NP.
Get vaccinated ASAP so we can get our lives back again. Love to all my fellow Texans out there and thanks to Gov Greg Abbott and Shannon Medical Center❤️👍🏻🇨🇱 ”
Paroex Chlorhexidine Gluconate Oral Rinse, 4 oz and 16 oz - recalled due to Potential contamination with Burkholderia lata, USA
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... nc. (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 firstname.lastname@example.org 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 ”
Sportmix, Nunn Better, ProPac, and Others brand Dog and Cat Pet Food - recalled due to Aflatoxin Levels Exceed Acceptable Levels, USA
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.,... of 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 email@example.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
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 ”
SuperFresh Glen Rock, Lincoln Avenue, Glen Rock, NJ, USA
January 3, 2021 5:22 AM
“I bought 9lives canned cat food and 3 of 4 cans had been expired from 11/11/19. Their store is not offering refunds but if I had not looked at the date my cats would have got sick ”