These products were distributed in the United States, Canada, Dominican Republic, Dubai (UAE), Fiji, Guam, Guatemala, Jamaica, Puerto Rico, Panama, Trinidad & Tobago, and Kuwait. 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. Other medicines, such as acetaminophen, are available to treat pain and fever during pregnancy. 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. Wholesalers, distributors and retailers with an existing inventory of the lot being recalled, should stop use and distribution and quarantine the product immediately. They include aspirin-containing products, acetaminophen-containing products, ibuprofen-containing products, lidocaine-containing products, diphenhydramine, loperamide, and naproxen products. aspirin (162 mg), acetaminophen (250 mg) If NSAID treatment is deemed necessary between 20 to 30 weeks of pregnancy, limit use to the lowest effective dose and shortest duration possible. For the latest FDA MedWatch alerts, go here. Prescription NSAID labels will be revised to reflect the following information: BACKGROUND: The risk of heart attack and stroke with NSAIDs, either of which can lead to death, was first described in 2005 in the Boxed Warning and Warnings and Precautions sections of the prescription drug labels. Click Ok if you wish to continue to the website; otherwise, click Cancel to return to our site. MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Discontinue the NSAID if oligohydramnios occurs and follow up according to clinical practice. 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. [07/21/2014 - Press Release - American Health Packaging], Audience: Consumers and healthcare professionals, McNeil Consumer Healthcare and FDA notified healthcare professionals of a voluntary recall of certain over-the-counter (OTC) Children's and Infants' liquid products manufactured in the United States, including Tylenol, Motrin, Zyrtec, and Benadryl products. In addition, AHP voluntarily recalled Oxcarbazepine Tablets, 300 mg, lot #142544, Expiration Date, 02/2016. RECOMMENDATION: X-Gen is notifying its distributors and customers by emails and fax communications and is arranging for return of all recalled products. The Drug Facts labels already advise pregnant and breastfeeding women to ask a health care professional before using these medicines. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA). Infants already susceptible to the adverse effects of ibuprofen may be at a slightly higher risk if they receive medication from an impacted bottle. 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 above recommendations do not apply to low-dose 81 mg aspirin prescribed for certain conditions in pregnancy. Consumers should check with recalling firms for further details. BACKGROUND: Oxcarbazepine is used for treating certain types of seizures in patients with epilepsy. 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]. 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. They include aspirin-containing products, acetaminophen-containing products, ibuprofen-containing products, lidocaine-containing products, diphenhydramine, loperamide, and … CPSC does not control this external site or its privacy policy and cannot attest to the accuracy of the information it contains. Complications of prolonged oligohydramnios may include limb contractures and delayed lung maturation. For medical information questions or product complaints related to Oxcarbazepine Tablets, 300 mg or Ibuprofen Tablets, USP, 600 mg please contact American Health Packaging customer service at 1-800-707-4621 from 8am to 4pm EST. The products were packaged in 0.5 oz and 1 oz bottles. Consider ultrasound monitoring of amniotic fluid if NSAID treatment extends beyond 48 hours. Please use the below phone number for all media requests. 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 packaging of the products is not child resistant, posing a risk of poisoning if the contents are swallowed by young children. BACKGROUND: The published studies FDA reviewed reported on the potential risks associated with the following three types of pain medicines used during pregnancy. The drug product can be identified by physical description: white, oval-shaped, film-coated tablets, with IP 465 printed on one side. RECOMMENDATION: Notification of the recall has been sent to distributors who received the affected product with instructions on how to notify their customers. (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 … 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. Summary. Issued 20 February 2020, updated 24 February 2020. The higher concentration could cause nausea, vomiting, diarrhea, headache, stomach bleeding, and kidney damage, according to Tris-Pharma. Audience: Pediatrics, Cardiology, Critical Care Medicine. A large number of studies support this finding, with varying estimates of how much the risk is increased, depending on the drugs and the doses studied. The recalled lots of the product have been found to potentially have higher concentrations of ibuprofen. Pfizer concluded that the use of the product with an unmatched dosage cup marked in teaspoons rather than milliliters has a chance of being associated with potential overdose. In December of last year the pharmaceutical company recalled batches of infant ibuprofen over the concern they may have contained an increased amount of ibuprofen. Some units from these batches have been found to have higher levels of Ibuprofen concentration. Product: Ibuprofen and other non-steroidal anti-inflammatory drugs (NSAIDs). Pfizer, Inc. has notified wholesalers, distributors and retailers to arrange for return of any recalled product. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. ISSUE:  FDA is strengthening an existing label warning that non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) increase the chance of a heart attack or stroke. Juratoys Recalls Toy Trumpets Due to Choking Hazard, Target Recalls Infant Rompers Due to Choking Hazard, Target Recalls Infant-Toddler Girl’s One-Piece Rashguard Swimsuits Due to Choking Hazard, GSK Consumer Health Recalls Five Excedrin Brands Due to Failure to Meet Child Resistant Packaging Requirement; Risk of Poisoning, Graco Recalls Inclined Sleeper Accessory Included with Four Models of Playards to Prevent Risk of Suffocation, View CPSC contacts for specific areas of expertise, 4330 East West Highway Bethesda, MD 20814. Now to that major drug recall the makers of infant Ibuprofen dropped Trish pharma expanding it nationwide recall of some of its product. Some of the vials have been found to contain particulate matter. Federal law bars any person from selling products subject to a publicly announced voluntary recall by a manufacturer or a mandatory recall ordered by the Commission. Oligohydramnios is often, but not always, reversible with treatment discontinuation. 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/distributors/retailers that have the Ibuprofen Lysine Injection which is being recalled should stop using and return to their wholesaler/distributor, or to X-Gen or to Exela. 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. To date, Tris Pharma, Inc. has not received any reports of adverse events related to the lots of product that are the subject of this recall. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. FDA urges pregnant women to always discuss all medicines with their health care professionals before using them. 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. The original recall last November was for … The product was distributed nationwide to wholesalers and distributors for further distribution to hospitals and retail customers. Tris Pharma, Inc. has notified its customer by urgent recall notice and has arranged for the return of recalled products from retailers and distributors. Common side effects of NSAIDs include: stomach pain, constipation, diarrhea, gas, heartburn, nausea, vomiting, and dizziness. This recall is not being undertaken on the basis of adverse medical events. Tris Pharma is a fully integrated pharmaceutical company focused on the development of innovative medicines that address unmet patient needs. 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. 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. RECOMMENDATION: Healthcare professionals should talk with each patient about the benefits and risks of analgesic use during pregnancy, which may differ among patients and by treatment indication. As is the case with current prescription NSAID labels, the Drug Facts labels of over-the-counter (OTC) non-aspirin NSAIDs already contain information on heart attack and stroke risk. 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. This recall is being executed with the knowledge of the U.S. Food and Drug Administration. Consider ultrasound monitoring of amniotic fluid if NSAID treatment extends beyond 48 hours and discontinue the NSAID if oligohydramnios is found. BACKGROUND: Ibuprofen Lysine Injection is indicated to close a clinically significant patent ductus arteriosus (PDA) in premature infants weighing between 500 and 1500 g, who are no more than 32 weeks gestational age when usual medical management is ineffective. It is important to remember that CPSC and recalling firms urge consumers not to use recalled products. 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. Talk to your pharmacist or health care professional for help deciding which might be best. For instructions on returning product or additional assistance, call Stericycle at 1-800-805-3093 between the hours of 8 a.m. to 5 p.m. Tris Pharma, the manufacturer of the affected batches of the Ibuprofen Oral Suspension Drops USP, 50 mg per 1.25 mL, which were distributed at CVS and Walmart made the recall in January … ISSUE: FDA is warning that use of NSAIDs around 20 weeks or later in pregnancy may cause rare but serious kidney problems in an unborn baby. [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. (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 … Patients currently taking Bextra should contact their physicians to consider alternative treatments. OPEC cutting oil output 01:15. NSAIDs can increase the risk of heart attack or stroke in patients with or without heart disease or risk factors for heart disease. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Linking to this external site does not constitute an endorsement of the site or the information it contains by CPSC or any of its employees. are a class of medicines available by prescription and OTC. bottles for the recalled lots listed below: Tris Pharma, Inc. sold the affected lots of Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL to one customer, which distributed the lots into the US market. 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. Medicines including nonsteroidal anti-inflammatory drugs (NSAIDs), opioids, and acetaminophen can help treat severe and persistent pain. * Reports of serious and potentially life-threatening skin reactions, including deaths, in patients using Bextra. 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). 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. Tris Pharma, Inc. has notified its customer by urgent recall notice and is arranging for the return of the recalled product. 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. The product is used as a pain reliever/fever reducer and is packaged in ½ oz. Consumers can contact the company at 1-888-222-6036 and also at www.mcneilproductrecall.com, [04/30/2010 - Questions and Answers - FDA] [04/30/2010 - Press Release - McNeil Consumer Healthcare] [05/01/2010 - News Release - FDA], [01/15/2010 - Press Release - McNeil Consumer Healthcare] [12/18/2009 - Press Release - McNeil Consumer Healthcare], The names of the products and manufacturers that received warning letters are:  Emuprofen (Progressive Emu, Inc.) BioEntopic 15% Ibuprofen Creme (BioCentric Laboratories, Inc.) Ibunex Topical Ibuprofen (Core Products International, Inc.) LoPain AF 15% Ibuprofen Creme (Geromatrix Health Products) IB-RELIEF (MEKT LLC) Profen HP (Ridge Medical Products) IbuPRO-10 Plus (Meditrend, Inc. dba Progena Professional Formulations) IBU-RELIEF 12 (Wonder Laboratories), Audience: Healthcare professionals and consumers. The expiration date for tablets and creams can be found on either the top or side panels of the container carton in the format [YEAR/MO]. 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. 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 … * Lack of any demonstrated advantages for Bextra compared with other NSAIDs. Pfizer, Inc. places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process. 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. Symptoms may include: ... , FDA Safety Recalls, … 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. Adverse effects that may be experienced are nausea, vomiting, epigastric pain, or more rarely, diarrhea. 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 . Sat, Dec 12, 2020 LOGIN Subscribe The products were packaged in 0.5 oz and 1 oz bottles. You may wish to review the privacy policy of the external site as its information collection practices may differ from ours. This recall is the result of mislabeled inner unit dose blister packaging which could result in patients receiving ibuprofen and missing their scheduled dose of oxcarbazepine. A pharmaceutical company that distributes liquid ibuprofen to CVS and Walmart is expanding a recall of its infant ibuprofen products. This can lead to low levels of amniotic fluid surrounding the baby and possible complications. 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]. Because of this uncertainty, the use of pain medicines during pregnancy should be carefully considered. Phone: (301) 504-7908 CVS Health: Infants’ Ibuprofen Concentrated Oral Suspension. The retailers should stop further distribution of the affected lots, which are being recalled.