The Food and Drug Administration (FDA) has announced that several lots of extended-release metformin — a popular type 2 diabetes drug — contain high levels of a cancer-causing contaminant called N-Nitrosodimethylamine (NDMA). There is a remote probability that infants, who may be more susceptible to a higher potency level of drug, may be more vulnerable to permanent NSAID-associated renal injury. NDMA was also detected in multiple other prescription and over-the-counter (OTC) medications, including The overall risk of developing cancer from medications contaminated with small amounts of NDMA is low. The recall is the subject of a congressional probe into what some Democratic lawmakers say was a … Pfizer, Inc. has notified wholesalers, distributors and retailers to arrange for return of any recalled product. 679215 Registered office: 1 London Bridge Street, London, SE1 9GF. Pfizer, Inc. places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process. News Corp is a network of leading companies in the worlds of diversified media, news, education, and information services.SUPERMARKETS are still facing a shortage of ibuprofen months after The Sun revealed a worldwide shortage.Customers have said they are struggling to buy the painkiller from stores including Tesco, Morrisons and Sainsbury’s.They confirmed to the Sun Online today that it is still an issue.Scores of customers have posted on social media after finding empty shelves.One Morrisons customer wrote on Twitter: “Been in two @Morrisons and shelves are empty in both. Tris Pharma, Inc. has notified its customer by urgent recall notice and is arranging for the return of the recalled product.Wholesalers and retailers of the product should stop further distribution of the affected lots of Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, which are being recalled.Consumers with questions regarding this recall can contact Tris Customer Service at 732-940-0358 (Monday through Friday, 8:00am ET- 5:00pm PT) or via email at Adverse reactions or quality problems associated with the use of this product may be reported to FDA's MedWatch Adverse Event Reporting program either by phone, on line, by regular mail or by fax.This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.Tris Pharma is a fully integrated pharmaceutical company focused on the development of innovative medicines that address unmet patient needs. FDA is also asking manufacturers of all marketed prescription NSAIDs, including Celebrex (celecoxib), a COX-2 selective NSAID, to revise the labeling (package insert) for their products to include a boxed warning and a Medication Guide. The Medication Guide will accompany every prescription NSAID at the time it is dispensed to better inform patients about the CV and GI risks. We are working with our suppliers to manage this. FDA is also asking manufacturers of all marketed prescription NSAIDs, including Celebrex (celecoxib), a COX-2 selective NSAID, to revise the labeling (package insert) for their products to include a boxed warning and a Medication Guide. ""Rather than doing the right thing and announcing a recall, we have learned that the drug company hired contractors to basically sneak into stores to purchase the products as if they were legitimate customers," Towns said in a statement last week. Wholesalers, distributors and retailers with an existing inventory of the lot being recalled, should stop use and distribution and quarantine the product immediately. FULL RECALLED PRODUCT LIST: Product Form Product Name Lot Number UPC Code CHILDREN'S CAPLET Junior Strength Motrin IB Caplet 24 ct AJM322 300450498243 MOTRIN … The recalled lots of the product have been found to potentially have higher concentrations of ibuprofen.There is a remote possibility that infants, who may be more susceptible to a higher potency level of drug, and therefore may be more vulnerable to permanent NSAID-associated renal injury. Neither Exela nor X-Gen has received any reports of adverse events related to this recall.The product was distributed nationwide to wholesalers and distributors for further distribution to hospitals and retail customers.Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:Prescription NSAID labels will be revised to reflect the following information:Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:Severe and persistent pain that is not effectively treated during pregnancy can result in depression, anxiety, and high blood pressure in the mother.