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. Equate: Infants’ Ibuprofen Concentrated Oral Suspension. Pfizer, Inc. has notified wholesalers, distributors and retailers to arrange for return of any recalled product. * Lack of any demonstrated advantages for Bextra compared with other NSAIDs. 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. For over-the-counter (OTC) NSAIDs intended for use in adults, FDA will also update the Drug Facts labels. 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. 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. Amazon.com from June 2018 through June 2020 for between $2 and $59. It is important to remember that CPSC and recalling firms urge consumers not to use recalled products. 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. In addition, AHP voluntarily recalled Oxcarbazepine Tablets, 300 mg, lot #142544, Expiration Date, 02/2016. Adverse effects that may be experienced are nausea, vomiting, epigastric pain, or more rarely, diarrhea. 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. Select one or more newsletters to continue. [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. 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 Talk to your pharmacist or health care professional for help deciding which might be best. And in January … Available for Android and iOS devices. (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 … [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. However, as a precautionary measure, parents and caregivers should not administer these products to their children. As a result, FDA evaluated research studies published in the medical literature and determined they are too limited to make any recommendations based on these studies at this time. Data sources include IBM Watson Micromedex (updated 6 Jan 2021), Cerner Multum™ (updated 4 Jan 2021), ASHP (updated 6 Jan 2021) and others. RECOMMENDATION: X-Gen is notifying its distributors and customers by emails and fax communications and is arranging for return of all recalled products. 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 … You may wish to review the privacy policy of the external site as its information collection practices may differ from ours. Continue to follow the existing recommendations in current drug labels regarding the use of analgesics during pregnancy. 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]. bottle, Equate: Infants’ Ibuprofen Concentrated Oral Suspension, USP, 50 mg per 1.25 mL, in 1.0 oz. 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. 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. BACKGROUND: The published studies FDA reviewed reported on the potential risks associated with the following three types of pain medicines used during pregnancy. Call CPSC’s Hotline at 800-638-2772 (TTY 301-595-7054). are available alone and combined with other medicines. 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. Children’s Advil® Suspension Bubble Gum Flavored 4 FL OZ Bottle temporarily reduces fever, relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches. 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. Consumers should contact their healthcare provider if they have experienced any problems that may be related to taking or using this drug product. 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. [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. OPEC cutting oil output 01:15. 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]. CVS Health: Infants’ Ibuprofen Concentrated Oral Suspension. 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. bottle, Equate: Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 ml, in 0.5 oz. The product is packaged in three 2 mL Single-Dose vials per carton. Failure to receive the proper dose of oxcarbazepine could increase the chances of having a seizure. Because of this uncertainty, the use of pain medicines during pregnancy should be carefully considered. Phone: (301) 504-7908 FDA will also request updates to the OTC non-aspirin NSAID Drug Facts labels. 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. Wholesalers, distributors and retailers that have further distributed the recalled product sh… These products were distributed in the United States, Canada, Dominican Republic, Dubai (UAE), Fiji, Guam, Guatemala, Jamaica, Puerto Rico, Panama, Trinidad & Tobago, and Kuwait. Pfizer Consumer Healthcare, a division of Pfizer Inc., is voluntarily recalling one lot of Children’s Advil® Suspension Bubble Gum Flavored 4 FL OZ Bottle because of customer complaints that the dosage cup provided is marked in teaspoons and the instructions on the label are described in milliliters (mL). 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). ET, Monday through Friday. bottles. The risk may increase with longer use of the NSAID. March 20, 2020 For immediate release. Based on FDAs comprehensive review of new safety information, FDA is requiring updates to the drug labels of all prescription NSAIDs. 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. 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. aspirin (162 mg), acetaminophen (250 mg) They include aspirin-containing products, acetaminophen-containing products, ibuprofen-containing products, lidocaine-containing products, diphenhydramine, loperamide, and naproxen products. This voluntarily recall includes the six (6) lots listed below: Tris Pharma, Inc. manufactures Ibuprofen Oral Suspension Drops, USP for a single customer, who markets and distributes the product to retailers. Please use the below phone number for all media requests. 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. In general, patients with heart disease or risk factors for it have a greater likelihood of heart attack or stroke following NSAID use than patients without these risk factors because they have a higher risk at baseline. Inadvertent consumption of ibuprofen may cause adverse reactions in a number of patients in which use of ibuprofen is contraindicated. Their hours of operation are Mon-Fri, 9am-5pm EST. There is an increased risk of heart failure with NSAID use. 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. The 31 different recalled products are listed in the table below: Medi-First Extra Strength Non-Aspirin Acetaminophen, acetaminophen (110 mg) 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. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. Discontinue the NSAID if oligohydramnios occurs and follow up according to clinical practice. Some units from these batches have been found to have higher levels of Ibuprofen concentration. 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. 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 … Tris Pharma's recent recall of infant ibuprofen comes less than a year after federal regulators told the drugmaker to clean up its act, citing numerous … For more information, please visit www.trispharma.com. 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]. 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 … If you are pregnant, do not use NSAIDs at 20 weeks or later in pregnancy unless specifically advised to do so by your health care professional because these medicines may cause problems in your unborn baby. The product is used as a pain reliever/fever reducer and is packaged in ½ oz. The Drug Facts labels already advise pregnant and breastfeeding women to ask a health care professional before using these medicines. The products were packaged in 0.5 oz and 1 oz bottles. RECOMMENDATION: Notification of the recall has been sent to distributors who received the affected product with instructions on how to notify their customers. Deaths, injuries, and property damage from consumer product incidents cost the nation more than $1 trillion annually. A recall is a voluntary action taken by a company at any time to remove a defective drug product from the market. 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. Following is a list of possible medication recalls, market withdrawals, alerts and warnings. Wholesalers, distributors and retailers with an existing inventory of the lot being recalled, should stop use and distribution and quarantine the product immediately. Tris' Nobuse™ technology provides abuse deterrence for opioids and other abuse-prone drugs. 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. 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. Particulate matter has the potential to block blood vessels, provoke an immune reaction, and/or lead to microinfarcts which could be life threatening. Family Wellness: Infants’ Ibuprofen Concentrated Oral Suspension. 3 Jan 2020, 17:14 Updated : 8 Jan 2020, 0:07 A RECALL was issued for infant ibuprofen last year after a company found some of its batches had higher concentrations of the medication. CPSC does not control this external site or its privacy policy and cannot attest to the accuracy of the information it contains. MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Sat, Dec 12, 2020 LOGIN Subscribe December 5, 2018 -- Tris Pharma, Inc. has voluntarily recalled three (3) lots of Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, to the retail level. Patients currently taking Bextra should contact their physicians to consider alternative treatments. A risk of heart attack or stroke can occur as early as the weeks... Dose products were packaged in 0.5 oz, Critical care Medicine: Notification of recalled! As arthritis, menstrual cramps, headaches, colds, and acetaminophen can help treat severe and persistent pain health... On the development of innovative medicines that address unmet patient needs six ( )... And GI risks following three types of pain medicines during pregnancy published studies FDA reviewed on... Treat pain and fever additional assistance, call Stericycle at 1-800-805-3093 between hours! May wish to review the privacy policy and can not attest to the Drug product is not being undertaken the. 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