This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. Patients taking NSAIDs should seek medical attention immediately if they experience symptoms such as chest pain, shortness of breath or trouble breathing, weakness in one part or side of their body, or slurred speech. The U.S. Consumer Product Safety Commission (CPSC) is charged with protecting the public from unreasonable risks of injury or death associated with the use of thousands of types of consumer products. Medicines including nonsteroidal anti-inflammatory drugs (NSAIDs), opioids, and acetaminophen can help treat severe and persistent pain. Symptoms may include: ... , FDA Safety Recalls, … Particulate matter has the potential to block blood vessels, provoke an immune reaction, and/or lead to microinfarcts which could be life threatening. Severe and persistent pain that is not effectively treated during pregnancy can result in depression, anxiety, and high blood pressure in the mother. Finally, FDA is asking manufacturers of non-prescription (OTC) NSAIDs to revise their labeling to include more specific information about the potential GI and CV risks, and information to assist consumers in the safe use of the drug. Claim: In December 2019, the FDA reported that Tris Pharma had announced a voluntary recall of several infant ibuprofen products. Thursday, January 31, 2019 The FDA issued an expanded recall of infants' oral ibuprofen solution because it may have potentially higher concentrations of ibuprofen than labeled. 31 Medique Over-the-Counter drugs from the product lines: Medi-First, Medi-First Plus, Medique, Dover, Otis Clapp, and Ecolab. Some units from these six (6) lots have been found to contain Ibuprofen as high as 10% above the specified limit. They are some of the most commonly used medicines for pain and fever. Recall of infant ibuprofen sold at Walmart, Family Dollar expanded Consumer Alerts & Scams Posted: Jan 2, 2020 / 09:02 AM CST / Updated: Jan 2, 2020 / 09:02 AM CST It is important to remember that CPSC and recalling firms urge consumers not to use recalled products. This can lead to low levels of amniotic fluid surrounding the baby and possible complications. For prescription NSAIDs, FDA is requiring changes to the prescribing information to describe the risk of kidney problems in unborn babies that result in low amniotic fluid. Contact Us: 800-638-2772 (TTY 800-638-8270), Toll Free Consumer Hotline | Time: 8 a.m. - 5.30. p.m. The product is used as a pain reliever/fever reducer and was packaged in 0.5 oz. The higher concentration could cause nausea, vomiting, diarrhea, headache, stomach bleeding, and kidney damage, according to Tris-Pharma. Tris' Nobuse™ technology provides abuse deterrence for opioids and other abuse-prone drugs. Children’s Advil® Suspension Bubble Gum Flavored 4 FL OZ Bottle, NDC 0573-0207-30, lot R51129 was distributed nationwide to wholesalers, distributors and retailers in the United States from May 2018 through June 2018. January 2, 2020 In December 2018, Tris Pharma, Inc. voluntarily recalled three lots of Infants ' Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL. The products were packaged in 0.5 oz and 1 oz bottles. The boxed warning will highlight the potential for increased risk of CV events with these drugs and the well-described, serious, and potentially life-threatening gastrointestinal (GI) bleeding associated with their use. ISSUE: Exela Pharma Sciences, in association with marketer X-Gen Pharmaceuticals, Inc., is voluntarily recalling lot number PLND1613 of Ibuprofen Lysine Injection, 20 mg /2 mL (10 mg/mL), vials to the hospital or user level. And in January … NEW JERSEY -- Tris Pharma has issued a voluntary recall of three lots of infants' ibuprofen concentrated oral suspension (liquid ibuprofen) that are being sold at Walmart, CVS and Family Dollar. The packaging of the products is not child resistant, posing a risk of poisoning if the contents are swallowed by young children. Consumers should contact their healthcare provider if they have experienced any problems that may be related to taking or using this drug product. These hospital unit dose products were distributed nationwide beginning June 20, 2014. The orignial recalled … Since then, FDA reviewed a variety of new safety information on prescription and OTC NSAIDs, including observational studies, a large combined analysis of clinical trials, and other scientific publications. Continue to follow the existing recommendations in current drug labels regarding the use of analgesics during pregnancy. This announcement does not apply to aspirin as it has clearly been shown to reduce the risk of serious adverse CV events in certain patient populations. Patients currently taking Bextra should contact their physicians to consider alternative treatments. Using its proprietary technology platform, LiquiXR®, Tris has pioneered the delivery of sustained release in the liquid, chewable, orally disintegrating tablet, and other dosage forms that benefits a wide variety of patients and their unique needs. Some units from these batches have been found to have higher levels of Ibuprofen concentration. Issue: We are aware of reports, including on social media, that reference safety issues with the use of ibuprofen in COVID-19 cases.There is no scientific evidence that establishes a link between ibuprofen … Oligohydramnios is often, but not always, reversible with treatment discontinuation. A pharmaceutical company that distributes liquid ibuprofen to CVS and Walmart is expanding a recall of its infant ibuprofen products. are used to treat medical conditions such as arthritis, menstrual cramps, headaches, colds, and the flu. Adverse effects that may be experienced are nausea, vomiting, epigastric pain, or more rarely, diarrhea. Read the McNeil Press Release below for a list of affected products. Issued 20 February 2020, updated 24 February 2020. Wholesalers, distributors and retailers with an existing inventory of the lot being recalled, should stop use and distribution and quarantine the product immediately. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Spanish: (301) 504-7800. Consumers should immediately store the recalled products in a safe location out of reach of children and contact Medique for information on how to dispose of the product and receive a full refund. The drug product can be identified by physical description: white, oval-shaped, film-coated tablets, with IP 465 printed on one side. bottles. work by blocking the production of certain chemicals in the body that cause inflammation. CPSC’s work to ensure the safety of consumer products has contributed to a decline in the rate of deaths and injuries associated with consumer products over the past 40 years. ET, Office of Equal Employment Opportunity and Minority Enterprise, Regulations, Mandatory Standards and Bans, Medique Recalls 31 Different Over The Counter Drugs Due To Failure To Meet Child, Report an Incident Involving this Product, Search Product Safety Reports on Saferproducts.gov, Report a dangerous product or a product-related injury on. FDA recommends that health care professionals should limit prescribing NSAIDs between 20 to 30 weeks of pregnancy and avoid prescribing them after 30 weeks of pregnancy. The FDA Alert(s) below may be specifically about Children's Motrin or relate to a group or class of drugs which include Children's Motrin (ibuprofen). You may wish to review the privacy policy of the external site as its information collection practices may differ from ours. For more information, please visit www.trispharma.com. 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 APM348 … Wholesalers, distributors and retailers that have further distributed the recalled product sh… The drug product can be identified by physical description: yellow color, capsule shaped, film-coated tablets scored and debossed with '1 84' on one side and scored on other side. Summary. Their hours of operation are Mon-Fri, 9am-5pm EST. This recall is not being undertaken on the basis of adverse medical events. [April 07, 2005 - Public Health Advisory - FDA][April 07, 2005 - Drug Information Page - FDA][April 07, 2005 - Questions and Answers - FDA], Audience: Pharmacists, other healthcare professionals, and consumers. These products were distributed in the United States, Canada, Dominican Republic, Dubai (UAE), Fiji, Guam, Guatemala, Jamaica, Puerto Rico, Panama, Trinidad & Tobago, and Kuwait. * The lack of adequate data on the cardiovascular safety of long-term use of Bextra, along with the increased risk of adverse cardiovascular (CV) events in short-term coronary artery bypass surgery (CABG) trials that FDA believes may be relevant to chronic use. Pfizer, Inc. places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process. Consumers, patients and health care professionals 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: [10/15/2020] - Drug Safety Communication - FDA]. Call CPSC’s Hotline at 800-638-2772 (TTY 301-595-7054). 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. Family Wellness: Ibuprofen Oral Suspension Drops. Some of the vials have been found to contain particulate matter. * Lack of any demonstrated advantages for Bextra compared with other NSAIDs. Consumers with questions regarding this recall may contact Tris Customer Service by 732-940-0358 (Monday through Friday, 8:00 AM ET- 5:00 PM PT) or via email at micc_tris@vigilarebp.com. These labels already warn to avoid using NSAIDs during the last 3 months of pregnancy because the medicines may cause problems in the unborn child or complications during delivery. Sat, Dec 12, 2020 LOGIN Subscribe [01/09/2015 - Drug Safety Communication - FDA], Audience: Pharmacy, Neurology, Pain Management, Rheumatology, ISSUE: American Health Packaging (AHP) voluntarily recalled Lot #142588, Expiration Date, 01/2016 of Ibuprofen Tablets, USP, 600 mg, in a hospital unit dose presentation that may contain individual blistered doses labeled as Oxcarbazepine Tablets, 300 mg, lot #142544. November 2020 … The retailers should stop further distribution of the affected lots, which are being recalled. Product: Ibuprofen and other non-steroidal anti-inflammatory drugs (NSAIDs). Click Ok if you wish to continue to the website; otherwise, click Cancel to return to our site. bottle, Equate: Infants’ Ibuprofen Concentrated Oral Suspension, USP, 50 mg per 1.25 mL, in 1.0 oz. Studies have shown that safety issues or toxicity is generally accepted to be a concern in infants at doses in excess of 700% of the recommended dose.1 To date, no serious adverse events have been reported related to this recall. FDA urges pregnant women to always discuss all medicines with their health care professionals before using them. aspirin (250 mg). Audience: Pediatrics, Cardiology, Critical Care Medicine. March 20, 2020 For immediate release. Cartons of 100 count (10x10) Hospital Unit Dose blisters of AHP Ibuprofen Tablets, USP, 600 mg, with outer carton NDC#: 68084-703-01 and individual dose NDC#: 68084-703-11, Lot #142588, Expiration Date, 01/2016. Recalled acetaminophen-containing products. For the latest FDA MedWatch alerts, go here. A pharmaceutical company that distributes liquid ibuprofen to CVS and Walmart is expanding a recall of its infant ibuprofen products. bottle. ET, Monday through Friday. RECOMMENDATION: X-Gen is notifying its distributors and customers by emails and fax communications and is arranging for return of all recalled products. RECOMMENDATION: Notification of the recall has been sent to distributors who received the affected product with instructions on how to notify their customers. All of the bottles were labeled as a "Concentrated Ibuprofen Oral Suspension, USP" with a concentration of 50 mg of ibuprofen per 1.25 mL. If consumers have questions regarding this recall or to report an adverse event, please contact the Pfizer Consumer Healthcare Information Line at 1-800-88-Advil (1-800-882-3845). MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Complications of prolonged oligohydramnios may include limb contractures and delayed lung maturation. We did use Vicks VapoRub and take vitamin C for colds. Pfizer, Inc. has notified wholesalers, distributors and retailers to arrange for return of any recalled product. These adverse outcomes are seen, on average, after days to weeks of treatment, although oligohydramnios has been infrequently reported as soon as 48 hours after NSAID initiation. The link you selected is for a destination outside of the Federal Government. Many OTC medicines contain NSAIDs, including those used for pain, colds, flu, and insomnia, so it is important to read the Drug Facts labels to find out if the medicines contain NSAIDs. As currently described in the NSAID labels, avoid prescribing NSAIDs at 30 weeks and later in pregnancy because of the additional risk of premature closure of the fetal ductus arteriosus. December 23, 2020 AvKARE Issues Voluntary Nationwide Recall of Sildenafil 100mg Tablets and Trazodone 100mg Tablets Due to Product Mix-Up December 9, 2020 -- AvKARE, Pulaski, TN is voluntarily recalling … Q: My dad was a pharmacist, yet as a kid I don’t recall taking a lot of medicines. The product is used as a pain reliever/fever reducer and is packaged in ½ oz. The product is packaged in three 2 mL Single-Dose vials per carton. Tris Pharma, Inc. has notified its customer by urgent recall notice and is arranging for the return of the recalled product. Available for Android and iOS devices. The risk of these reactions in individual patients is unpredictable, occurring in patients with and without a prior history of sulfa allergy, and after both short- and long-term use. The expiration date is found on the bottom for the spray cans. Infants already susceptible to the adverse effects of ibuprofen may be at a slightly higher risk if they receive medication from an impacted bottle. Tris Pharma recalls several lots of its infant ibuprofen product after finding that the painkiller might be more potent than previously stated. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. (WTNH) — New Jersey-based pharmaceutical company, Tris Pharma Inc., has expanded its voluntary recall of its infants’ liquid ibuprofen after discovering higher concentrations of the … Inadvertent consumption of ibuprofen may cause adverse reactions in a number of patients in which use of ibuprofen is contraindicated. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA). Newer information makes it less clear that the risk for heart attack or stroke is similar for all NSAIDs; however, this newer information is not sufficient for us to determine that the risk of any particular NSAID is definitely higher or lower than that of any other particular NSAID. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. However, it is important to carefully weigh the benefits and risks of using prescription and OTC pain medicines during pregnancy. See the FDA Drug Safety Communication Data Summary section for more information about these studies. Consider ultrasound monitoring of amniotic fluid if NSAID treatment extends beyond 48 hours and discontinue the NSAID if oligohydramnios is found. 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. These studies were also discussed at a joint meeting of the Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee held on February 10-11, 2014. FRESNO, Calif. (KFSN) -- Tris Pharma, Inc. has expanded its voluntary recall of infant liquid ibuprofen by adding three more lots that were sold at Walmart and CVS Pharmacy. Now to that major drug recall the makers of infant Ibuprofen dropped Trish pharma expanding it nationwide recall of some of its product. The risk may increase with longer use of the NSAID. The original recall last November was for … Tris’ research, manufacturing and commercial facilities are located in Central New Jersey. Because of this uncertainty, the use of pain medicines during pregnancy should be carefully considered. Examples of NSAIDs include. Consumers who have received the recalled product should immediately discontinue use and contact GENCO Pharmaceutical Services at 855-419-4608 from 7am to 5pm CST for instructions on returning the recalled product. 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. CPSC.gov is an official website of the United States government. A recall is a voluntary action taken by a company at any time to remove a defective drug product from the market. The recall involves 31 different over-the-counter drugs purchased on or after June 1, 2018 that are unexpired from the following brands:  Medi-First, Medi-First Plus, Medique, Dover, Otis Clapp, and Ecolab. In some postmarketing cases of impaired neonatal renal function, invasive procedures such as exchange transfusion or dialysis were required. ISSUE:  FDA is aware of and understands the concerns arising from recent reports questioning the safety of prescription and over-the-counter (OTC) pain medicines when used during pregnancy. 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 Customer Service Email . The Medication Guide will accompany every prescription NSAID at the time it is dispensed to better inform patients about the CV and GI risks. If NSAID treatment is deemed necessary between 20 to 30 weeks of pregnancy, limit use to the lowest effective dose and shortest duration possible. Wholesalers, distributors and retailers with an existing inventory of the lot being recalled, should stop use and distribution and quarantine the product immediately. Ibuprofen recall: pharmaceutical company warns of its own medication 2020-02-05T20:37:50.273Z Anyone taking certain medicines should definitely check the batch: a manufacturer recalls numerous … Drug Recall List Last Updated: November 2020 Drug Recall Details Contact Date Drug Recall Class* Lansoprazole Delayed-Release Orally Disintegrating Tablets 06838277177 Failed Dissolution Specifications If you have questions about this recall, Zydus Pharmaceuticals, 1-877-993-8779. Patients treated with NSAIDs following a first heart attack were more likely to die in the first year after the heart attack compared to patients who were not treated with NSAIDs after their first heart attack. Other medicines, such as acetaminophen, are available to treat pain and fever during pregnancy. Updated December 30, 2020 If you are a consumer or patient ... Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. It was previously thought that all NSAIDs may have a similar risk. The risk of heart attack or stroke can occur as early as the first weeks of using an NSAID. The risk appears greater at higher doses. All known purchasers are being notified directly. 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: [02/08/2017 - Press Release - Exela Pharma Sciences]. BACKGROUND: Oxcarbazepine is used for treating certain types of seizures in patients with epilepsy. The over-the-counter products contain regulated substances which must be in child resistant packaging when being used in the household as required by the Poison Prevention Packaging Act (PPPA).