RELATED: If You Bought Any of These 6 Supplements, Throw Them Away Now, FDA Says. On Dec. 7, the FDA announced that Teligent Pharma, Inc. was voluntarily recalling two lots of 50-ml. screw cap glass bottles containing Lidocaine HCl Topical Solution USP 4%.ae0fcc31ae342fd3a1346ebb1f342fcb The affected medications can be identified by NDC number 63739-997-64, lot number 15594, and expiration date 05/2023 or NDC number 63739-997-64, lot number 16345, and expiration date 01/2024. For the latest recall news delivered straight to your inbox, sign up for our daily newsletter! The recall was initiated after it was discovered that the medication, which is used as a topical anesthetic for the mouth, nose, and adjacent portions of the GI tract, was “super potent.” “The firm’s testing has found it to be super potent based on an Out of Specification (OOS) result obtained at the 9-month (Lot 16345) and 18-month (Lot 15594) stability timepoint,” the recall notice explains. The medication was distributed to customers throughout the U.S. at wholesale and retail locations. Teligent Pharma had recalled four lots of Lidocaine in Oct. 2021 because of the same issue. The medication’s super potency could lead to users developing Lidocaine toxicity, a potentially serious condition that can result in major health problems. This may include “excitation and/or depression and more serious signs of cardiovascular toxicity, such as bradycardia, hypotension, and even cardiovascular collapse,” and may even lead to death, the recall notice warns. These symptoms are more likely to occur in children and the elderly, but may affect others, as well. At the time the recall was announced, the company had received no reports of illness or injury related to the use of the recalled Lidocaine. If you are in possession of Lidocaine from the affected batches, stop using it immediately and return it to the store from which it was purchased. If you have questions about the recall or would like to receive a refund, you can contact Teligent Pharma, Inc. at 856-697-1441, followed by the star key, on weekdays from 8 a.m. to 5 p.m. or at [email protected] The company will also be contacting known distributors to arrange for the return of the medication. If you have used the affected Lidocaine and believe you’ve had a reaction, contact a healthcare professional immediately. RELATED: If You Bought These Old Spice or Secret Deodorants, Throw Them Out Now.
title: “If You Use This Medication Stop Immediately Fda Says Best Life” ShowToc: true date: “2022-12-04” author: “Ruth Smith”
RELATED: If You Take This Medication, Call Your Doctor Now, FDA Says. On Sept. 8, the FDA announced that Azurity Pharmaceuticals, Inc. is voluntarily recalling 2,751 kits of Firvanq 50 mg/mL from lot number 21035. The medication, used to treat diarrhea associated with Clostridium difficile and enterocolitis associated with staphylococcus aureus, can be identified by NDC number 65628-206-05, UPC number 3 65628 206005 1, and expiration date 2022-07-31. For the latest recall news delivered straight to your inbox, sign up for our daily newsletter. Firvanq kits are supposed to contain Vancomycin Hydrochloride, USP powder, and a grape-flavored dilutant. The Firvanq kits in the recalled lot are accompanied by a bottle of First Omeprazole, a medication used to treat overproduction of acid in the stomach, instead of the appropriate dilutant. According to Azurity Pharmaceuticals, the inclusion of the incorrect dilutant with the kits may pose a serious health risk to individuals using the recalled Firvanq lot. Azurity Pharmaceuticals explains that inclusion of the incorrect dilutant “could lead to doses above or below those recommended in the label.“ae0fcc31ae342fd3a1346ebb1f342fcb They add that there’s “reasonable probability” that these incorrect doses can lead to a whole host of issues, including “persistent diarrhea associated with dehydration and electrolyte abnormalities, recurrence of Clostridium difficile (C. difficile) infection, its progression to severe colitis, colon perforation requiring colectomy, and potentially death,” the company explains. Individuals with compromised immune systems and older adults are particularly at risk of complications, although at the time the recall was announced, no adverse effects related to use of the affected medication had been reported. If you are in possession of one of the recalled Firvanq kits and are experiencing symptoms, contact a healthcare provider immediately. Azurity Pharmaceuticals says anyone with the recalled medication should stop using it immediately and return it to the pharmacy or medical office from which it was purchased. Azurity Pharmaceuticals is also reaching out to customers and distributors to arrange for the recalled products’ return. If you have questions related to the recall, contact Azurity Pharmaceuticals Senior Manager of Customer Services Koral Couch at 781-935-8141 x 119 from 8:30 a.m. to 5 p.m. ET or at [email protected] anytime. RELATED: If You Take This Popular Medication, Talk to Your Doctor Now, FDA Says.
