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Teligent Lidocaine HCl Topical Solution 4% - recalled due to Super potency, USA

2 years ago source www.fda.gov

Recall notice

United States

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 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 www.fda.gov

Source: FDA

#drugs #recall #us

Recent Interesting Reports

Cargill’s animal nutrition business is conducting a voluntary recall of Nutrena® Country Feeds® Meat bird 22% Crumble (RV) due to non-inclusion of Vitamin D. The affected products were manufactured and sold in the eastern United States and are being recalled from retail outlets in the Alabama, Georgia, … See More
Florida, North Carolina, South Carolina, Tennessee, Virginia, and West Virginia markets. Cargill discovered the issue after receiving a report of young meat birds diagnosed with rickets.

Lack of Vitamin D in meat bird diets can lead to mineral deficiencies and bone issues, including rickets in growing birds. Symptoms include lameness and rubbery bones.

The recalled product is:
- Product: Nutrena® Country Feeds® Meatbird 22% Crumble (RV), Size: 50 lb. bag, Lot Code: All lots, Product Code: 95188, Species: Meat birds (Broilers, Turkeys, Ducks, Geese and Pheasants, Manufacture dates: July 2022-March 2024, Shelf Life (Days): 120.
The lot code and manufacture date can be found on the bottom right-hand side of the label.

Consumers and other end users who have any of the affected lots in their possession should return remaining product to their local dealer or retailer for a replacement or full refund.

In case your birds experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance.

Company name: Cargill
Brand name: Nutrena Country Feeds
Product recalled: Meat bird 22% Crumble (RV)
Reason of the recall: Non-inclusion of Vitamin D
FDA Recall date: April 13, 2024

Source: www.fda.gov
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#petfood #cargill #recall #brysoncity #northcarolina #us

P
Co. Name. KetoGenesis Keto+Acv P.O.Box 81827 Las Vegas NV 89810-1827. DID LOOK AT THIS PRODUCT FOR ABOUT $ 40.00. BUT DECIDED NOT 2 ordered. Was going to pay for shipping. Took get same thing on Amazon. 5 bottles 4 $80.00. They did charge my credit card $198.78 .I'm still trying 2 get my refund.

#unauthorizedcreditcardcharge #onlineshopping #scam #onlinescam #delivery #lasvegas #nevada #us

W
I received this package in the mail and I never ordered anything, from this place called Fullfillment House PO Box 10205 Tampa FL 33679-0205, they have charged me 3 x on my credit card, first charges was on March 24 2024 one charge for $ 60.09, and … See More
another charge for $99.00 on the same day, then again on April 4 2024 for 60.09.
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#unorderedpackage #delivery #uspostalservice #eastpointe #michigan #us

G

Scam Alert, Avon Park, Florida, USA

5 days ago reported by user-gbffn257

I was told and shown big lucky boxes worth 100$ or more, I got a cheap no name brand ear buds and a phone charger. Not worth more then 15$. I got rip-off and would like to return and get money back. It’s a community issue if you see how many people got taken also!

#scam #onlineshopping #onlinescam #delivery #avonpark #florida #us

T

Facebook Scam, Interlachen, FL, USA

2 weeks ago reported by user-tfjp9313

Two drums that I just reported to you that I received and did not even order. They pulled my credit card off of my computer without my permission and I have no idea what credit card they use or anything. I have no idea what the things … See More
cost. They just show

I looked at these drones on Facebook. I put my first name in my last name, and after that I left the site didn’t think a thing about it did not give them any personal information whatsoever. Apparently, they are able to pull your credit card off of your computer because the next thing I know I’ve got two Drones sitting at my house Not even want these cheap things there is no way of sending them back. There is no invoice. There is no nothing so I have no idea how to take care of this. I looked up their name their address in New York no longer in business..
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#subscriptionscam #scam #delivery #facebookscam #interlachen #florida #us

Last 30 days