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Power Outage, Toledo, OH, USA

2 days ago

Toledo, Ohio, United States

More than 20,000 people lost power in Lucas County as a line of severe storms swept through the area Tuesday night.

According to the FirstEnergy outage map as of 10:40 p.m., 22,949 people were without power throughout the state, with the vast majority of 19,931 reported in Toledo and another 1,043 in Washington Twp.

The areas of Laskey and Jackman, the Old West End and Point Place bore the brunt of the outages.

Outage link: outages.firstenergycorp.com

Source: wtol.com
Source publication date: 2021 09 14

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Company name: Teligent Pharma, Inc.
Brand name: Teligent
Product recalled: Lidocaine HCl Topical Solution 4%
Reason of the recall: Super potency
FDA Recall date: August 30, 2021
Recall details: Teligent Pharma, Inc. is voluntarily recalling one lot of Lidocaine HCl Topical Solution 4%, 50ml in a screw... See More cap glass bottle to the user level. The product is being recalled because the firms testing has found it to be super potent based on an Out of Specification (OOS) result obtained at the 18-month stability timepoint.

Risk Statement: Use of the super potent product would result in a higher than intended lidocaine dose above that intended.  An increased lidocaine dose could lead to the development of local anesthetic systemic toxicity depending on the duration of the treatment and the specific patient.  Local anesthetic systemic toxicity can result in central nervous system reactions including excitation and/or depression and more serious signs of cardiovascular toxicity, such as bradycardia, hypotension, and even cardiovascular collapse can present very quickly.

If local anesthetic systemic toxicity is not recognized and treated quickly, severe morbidity and even death can result. Adults and the elderly who are more likely to use this product as well as children of lower body weight are more likely to experience local anesthetic systemic toxicity if a higher than intended lidocaine concentration is administered.

To date, Teligent Pharma, Inc. has not received any reports of adverse events related to this recall. The product is indicated for the production of topical anesthesia of accessible mucous membranes of the oral and nasal cavities and proximal portions of the digestive tract and is packaged in a 50ml glass bottle with a screw cap with the identification NDC# 52565-009-50.  The affected Lidocaine HCl Topical Solution 4% lot number and expiration date are:  Lot # 14218, Exp. 09/2022.  The product can be identified by the following labeling:  Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL).  

Product was distributed at the wholesale and retail distribution levels in the US and Canada. Teligent Pharma, Inc. is notifying its distributors via Fed-Ex and is arranging for return of all recalled products. Distributors, consumers, and patients that have Lidocaine HCl Topical Solution 4% which is being recalled should return product to their place of purchase.

Consumers with questions regarding this recall can contact Teligent Pharma, Inc. by phone at 1-856-697-1441 press * to reach the medical information call center Monday through Friday, 8am – 5pm. 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
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Company name: Jacobus Pharmaceutical Company Inc.
Brand name: Ruzurgi®
Product recalled: Ruzurgi® (amifampridine) 10 mg tablets
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FDA Recall date: September 13, 2021
Recall details: Plainsboro, New Jersey, Jacobus Pharmaceutical Company Inc. is voluntarily recalling 3... See More lots of Ruzurgi® (amifampridine) 10 mg tablets to the consumer level. The products have been found to be contaminated with yeast, mold, and aerobic bacteria based on laboratory test results.

Oral products heavily contaminated with yeast, mold, and aerobic bacteria may result in serious and life-threatening infections. The use of the defective product in patients with underlying immunosuppressive conditions such as Lambert Eaton Syndrome (LEMS) increases the concern for serious infections.

The product is used as a treatment for LEMS in patients ages 6 to less than 17 and is packaged in 100 count bottles (NDC: 49938-110-01). The affected Ruzurgi® (amifampridine) tablets lots include the following control numbers and expiration dates:
- Control Number 18038, Expiration 03/2023
- Control Number 18039, Expiration 03/2023
- Control Number 18079, Expiration 05/2023

The Control Number is located to the right of the bottle’s front panel below the D2 Barcode. Ruzurgi® (amifampridine) was distributed worldwide to specialty pharmacies and physicians.

Jacobus was informed of this issue by their Canadian partner that was conducting confirmatory full testing on Control Number 18038. Jacobus conducted an expanded investigation which identified Control Numbers 18039 and 18079.

- Control Number 18038 was distributed between 05/25/2021 – 08/26/2021 (Canada only)
- Control Number 18039 was distributed between 06/01/2021 – 08/10/2021
- Control Number 18079 was distributed between 08/10/2021 – 08/30/2021

Jacobus Pharmaceutical Company Inc is notifying its distributors and customers via regular mail and electronic mail and is arranging for the return of all recalled products.

Consumers that have Ruzurgi® (amifampridine) which is being recalled should stop using and return this product. Consumers with questions regarding this recall can contact Jacobus Pharmaceutical Company Inc. by phone at (609)799-8221 ext. 2120, Monday thru Friday from 9:00 AM to 5:00 PM Eastern Standard Time. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration and other health authorities.

Check the full recall details on fda.gov

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Company name: Top Quality Dog Food
Brand name: Top Quality Dog Food.com
Product recalled: Beef HVM
Reason of the recall: Potential Salmonella & Listeria monocytogenes contamination
FDA Recall date: August 26, 2021
Recall details: Top Quality Dog Food of Hyattsville, MD is recalling “Beef HVM” 1-pound packages... See More due to the potential of Salmonella spp., Listeria monocytogenes. Salmonella, Listeria, can affect animals eating the product and there is risk to humans handling contaminated 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 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.

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. Listeria monocytogenes can cause serious and sometimes fatal infections in young children, vulnerable or elderly people, and others with compromised immune systems. Healthy people may suffer short-term symptoms such as fever, headaches, stiffness, abdominal pain, and diarrhea. Listeria monocytogenes infections pose a serious threat to pregnant woman, as it can lead to miscarriages and stillbirths. Listeria monocytogenes infections are uncommon in pets, but they are possible. Symptoms may include mild to severe diarrhea; anorexia; fever; nervous, muscular, and respiratory signs; abortion; depression; shock; and death. Healthy people should monitor themselves and their pets for symptoms.

The recalled “Beef HVM” was distributed in DC, MD, VA, DE, PA, MA, CT, and SC and product was distributed through mail order and direct delivery from 7/27/21 to 8/2/21. The “Beef HVM” comes in a 1-pound package marked with lot #071521 on the bottom right corner of the label.

No illnesses have been reported to date in connection with the “Beef HVM” 1-pound packages in question.

The contamination was noted after a state surveillance sample revealed the presence of Salmonella, Listeria monocytogenes, in some 1-pound. packages of Beef HVM. The remaining “Beef HVM” batch in our possession has been quarantined and we have discontinued the distribution of this batch while FDA and our company continue their investigation as to the source of the contamination. 

We encourage all customers who received this product to dispose of any unused product immediately. If you find the “Beef HVM” 1-pound package that shows the lot number: 071521 in your possession, we urge you to return it to the place of purchase for a full refund.

Check the full recall details on fda.gov

Source: FDA
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Company name: ICU Medical, Inc.
Brand name: Hospira
Product recalled: Aminosyn II, 15%, An Amino Acid Injection, Sulfite
Reason of the recall: Presence of visible particulate matter
FDA Recall date: September 07, 2021
Recall details: ICU Medical, Inc. is voluntarily recalling one lot (2,112 units) of Aminosyn... See More II, 15%, An Amino Acid Injection, Sulfite Free intravenous (IV) solution to the hospital/user level due to the presence of visible particulate matter identified as fibers, hair, and proteinaceous material along with other particles. 

ICU Medical became aware of this issue while inspecting retain samples as part of routine process. Administration of a drug product that contains particulate matter could result in adverse events ranging from inflammation at the site of injection to more serious events that could include the formation of a blood clot obstructing the flow of blood which could lead to end-organ damage or death. 

To date, ICU Medical, Inc. has not received reports of adverse events or illnesses related to this recall. Aminosyn II, Sulfite-Free, (an amino acid injection) infused with dextrose by peripheral vein infusion is indicated as a source of nitrogen in the nutritional support of patients with adequate stores of body fat, in whom, for short periods of time, oral nutrition cannot be tolerated, is undesirable, or inadequate. 

Aminosyn II can be administered peripherally with dilute (5 to 10%) dextrose solution and I.V. fat emulsion as a source of nutritional support. This form of nutritional support can help to preserve protein and reduce the breakdown of organic or inorganic materials, such as proteins, sugars, fatty acids, etc. in stress conditions where oral intake is inadequate. Aminosyn II is also indicated for central vein infusion to prevent or reverse excreting more nitrogen than is being taken in in patients where the intestinal tract, by the oral, surgical opening into the stomach for the introduction of food or surgical procedure for a feeding tube routes cannot or should not be used and gastrointestinal absorption of protein is impaired. 

Product was distributed nationwide both by ICU Medical direct to customers and through medical distributors. The product is for human use only. ICU Medical acquired this product from Hospira, a Pfizer company; therefore, the affected product contains a Hospira NDC number and a Hospira label. The affected product lot, manufactured in the U.S. by ICU Medical in November 2020, is listed below:  

- Aminosyn® II 15% An Amino Acid Injection, Sulfite-Free. NDC: 0409-7171-17. Catalog Number: 07171-17. Lot Number: 4989094. Expiration Date: 01-Apr-2022. Configuration: Pharmacy Bulk. Package 2-liter. Flexible. Container. Manufacture Date: November 2020. Distribution Dates: January 2021 – March 2021.

ICU Medical is notifying its distributors and customers of this recall by letter and is arranging for the return of all recalled products.

Hospitals/distributors that have a product that is being recalled should stop use/further distribution and return to the place of purchase.

Customers with questions regarding this recall can call ICU Medical at 1-844-654-7780 Monday through Friday between the hours of 8 a.m. and 5 p.m. Central time. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using these drug products.

Check the full recall details on fda.gov

Source: FDA
See Less