Patients with underlying lung disease (especially cystic fibrosis) might be at increased risk for severe infections with B. The recall information provided below links to the manufacturers' and regulatory agencies' press releases for product sold through Walmart stores, Walmart.com, Sam's Club or Samsclub.com. The treatment, which comes in a 0.5-fluid-ounce white bottle inside an orange box, is used as a nasal decongestant. The nasal spray is distributed as "Major Twice-A-Day 12 Hour Nasal Spray." For the latest FDA MedWatch alerts, go here. ACCESSIBILITY, Morbidity and Mortality Weekly Report Product Quest Manufacturing (“Product Quest”) announced its voluntary recall of Lot# 173089J of CVS Health 12 Hour Sinus Relief Nasal Mist due to a finding of microbial contamination identified as Pseudomonas aeruginosa. For dry, irritated nasal passages due to allergies, cold, flu, sinusitis, and rhinitis. U.S. Government Printing Office (GPO), Washington, DC 20402-9371; telephone: (202) 512-1800. Nasacort is an ok nasal spray. POLICY  |  Spray this product into each nostril as needed or as directed by your doctor. Side effects, drug interactions, Dosage, and pregnancy and breastfeeding safety information are provided. |  The recall applies to all products made in its Florida plant, including nasal mists, sprays, and gels. MMWR SEARCH  |  Ocean® Saline Nasal Spray. Data sources include IBM Watson Micromedex (updated 2 Feb 2021), Cerner Multum™ (updated 3 Feb 2021), ASHP (updated 29 Jan 2021) and others. Department of Health and Human Services. The recall applies to Lot# 173089J of CVS Health 12 Hour Sinus Relief Nasal Mist, a nasal decongestant, according to the FDA statement.. In August a massive recall of nasal sprays was issued by Product Quest Manufacturing. the date of publication. Persons using assistive technology might not be able to fully access information in this file. In the treatment of runny nose and allergies , the most common nasal sprays include active ingredients from four categories: Saline nasal spray (Sodium Chloride, Ocean, Ayr Saline, Humist, Rhinaris, NaSal, Little Noses, Ocean for Kids) is an OTC product used to treat nasal congestion and as a pretreatment for nasal steroid administration. CDC has been notified of a voluntary recall of over-the-counter oxymetazoline HCl 0.05% nasal spray because of pages found at these sites. 1600 Clifton Rd, MailStop E-90, Atlanta, GA ... with an expiration date of September 2019. A recall has already been issued for the onions; however, ready-to-eat meats and salad products may contain the potentially tainted onions, which prompted the USDA to issue the public health alert. Doctor recommended brand. Centers for Disease Control and Prevention A nasal spray is any kind of medication that’s inhaled through the nose. (http://www.cdc.gov/mmwr). this product should be reported to the local or state health department and CDC, telephone 800-893-0485. Marketside, H.E.B., and Taylor Farms brands were included in the alert, with a total of 396 cases possibly linked to the salmonella outbreak. Hour Nasal Spray." Similarly, repetitive use of an oral gel product containing a pathogen can potentially lead to colonization and subsequent infection which can be life threatening in certain patient populations, including babies or very young children. Product Quest, the manufacturer of Ocean Saline Nasal Spray, has voluntarily recalled all Ocean Saline Nasal Spray. Available for Android and iOS devices. Learn about Bausch Health, a global company whose mission is to improve people’s lives with our health care products. Gentle enough for infants. For assistance, please send e-mail to: mmwrq@cdc.gov. ABOUT MMWR  |  endorsement of these organizations or their programs by CDC or the U.S. K4496, released in November The August recall impacted eight different store brand lines of nasal sprays. Includes travel size. More Buying Choices $5.29 (8 new offers) FSA or HSA eligible. Out of an abundance of caution, Product Quest has decided to expand the recall to include all lots of nasal products and baby oral gels currently within expiration that were manufactured at the company’s Florida facility. Product Quest Manufacturing (“Product Quest”) announced its voluntary recall of Lot# 173089J of CVS Health 12 Hour Sinus Relief Nasal Mist due to a finding of microbial contamination identified as Pseudomonas aeruginosa. Compare to the ingredients in ocean. This product may also be given into the nose as drops or a stream. For instance, the people working to manufacture the product can directly contaminate … Product Quest is notifying its customers by oral and written communication and is arranging for return/replacement etc. HOME  |  This item is FSA (Flexible Spending Account) eligible. The company provided a 63-page document listing over1,000 affected lots of various nasal … Consumers with questions regarding this recall can contact Product Quest Manufacturing LLC at 704-939-4342, Monday through Friday from 8 am to 4 pm, EST. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. To the best of Product Quest’s knowledge, the company has not received any reports of adverse events related to this recall to date. The FDA Alert(s) below may be specifically about Ocean or relate to a group or class of drugs which include Ocean. The product comes in 137 mcg/ 50 mcg per spray, 120 metered sprays, 23 g net fill weight bottle with an expiry in April 2019. Foster’s Food Fair-IGA would like to announce that Valeant Pharmaceutic has voluntarily issued a recall on Ocean Saline Nasal Spray due to a possible microbial contamination. On March 24, this notice was posted as an bags of Lay’s Barbecue Flavored Potato Chips because they may contain undeclared milk ingredients. There is no known microbial contamination associated with the nasal products and baby oral gels that are the subject of this expanded recall. One 1.5 fl … RSS PLANO, Texas – Aug. 24, 2020 – Frito-Lay today issued a voluntary recall of select 1 oz., 1 1/2 oz., 2 5/8 oz., 7 3/4 oz., 12 1/2 oz., 15 1/2 oz. Product Quest manufacturing, which recently announced a recall of CVS Health 12 Hour Sinus Relief Nasal Mist oxymetazoline nasal spray due to contamination with Pseudomonas aeruginosa, has now recalled all of the nasal products it manufactured at its Florida facility “out of an abundance of caution.”. Major Pharmaceuticals Deep Sea Generic for Ocean Nasal Moisturizing Spray 1.5 Fl Oz, Pack of 3. into HTML.   The recall affects Dymista, 137 mcg/50 mcg per spray, 120 metered … CDC is not responsible for the content The manufacturer (Propharma Inc., Miami, Florida) has recalled lot no. How to use Ocean Spray, Non-Aerosol. On March 24, this notice was posted as an MMWR Dispatch on the MMWR website ( http://www.cdc.gov/mmwr ). This conversion may have resulted in character translation or format errors in the HTML version. Contamination of pharmaceuticals can occur in a number of different ways. Adverse reactions or quality problems experienced with the use of these products may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Preliminary molecular epidemiology indicates that isolates related to the strain found in the nasal spray have Type 508 Accommodation and the title of the report in the subject line of e-mail. Recalled UPC # 30187526002. Product Quest is recalling the Ocean Saline Nasal Spray due to possible out of specification results related to microbial contamination. Product Name Ocean Saline Nasal Spray. Natural, non-medicated relief. cepacia complex. Mylan Pharmaceuticals Inc. is recalling 10,390 bottles of Dymista (azelastine hydrochloride and fluticasone propionate) nasal spray because of the potential for broken glass in the bottle. Safe for frequent, daily nasal care. Reason for Recall possible microbial contamination – Pseduomonas aeruginosa, a multidrug resistant pathrogen. DISCLAIMER  |  This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. Consumers/distributors/retailers that have product which is being recalled should stop using the product and return it to the place of purchase. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. been recovered from patients in multiple states. This recall should be carried out to the retail level. For the second time in eight days, Valeant Pharmaceuticals has made a sweeping all lots, all expiration dates DOWNLOADS  |  Original review: May 29, 2020. An original paper copy of this issue can be obtained from the Superintendent of Documents, Risk Statement: Repetitive use of a nasal spray or other nasal product containing a gram-negative pathogen can potentially lead to colonization and subsequent infection which can be life threatening in certain patient populations, such as those with cystic fibrosis or immune-compromised individuals. Recalled Lot (s) All lots all dates. CONTACT The recall was included in the February 13, 2019, US Food and Drug Administration (FDA) Enforcement Report. A microbial contamination is the possible exposure of a product to micro-organisms, such as fungi, bacteria, viruses and their biological by-product, which may cause disease and allergic responses to occupants. The nasal spray is distributed as "Major Twice-A-Day 12 If you use Ocean Nasal Spray (sodium chloride nasal) on a regular basis, use a missed dose as soon as you think about it. For dry nasal membranes squeeze twice in each nostril as needed. Major Pharmaceuticals Deep Sea Saline Generic for Ocean Nasal Moisturizing Spray… A CVS store-brand nasal spray is ... More than 16,000 units of the half-fluid ounce bottle are included in the recall. cepacia complex. MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Disclaimer Size 2.26oz. might have been exposed to B. cepacia complex. 4.7 out of 5 stars 3,050. Tips: Upright delivers a spray, horizontally a stream, upside down a drop. CDC has been notified of a voluntary recall of over-the-counter oxymetazoline HCl 0.05% nasal spray because of intrinsic contamination with Burkholderia cepacia complex. MMWR Dispatch on the MMWR website If it is close to the time for your next dose, skip the missed dose and go back to your normal time. 68 ($1.48/Fl Oz) FREE Shipping. The recall covers 16,896 packages with the … Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these drug products. Audience: Consumer, Health Professional, Pharmacy. Dymista nasal spray is indicated for the relief of symptoms of seasonal allergic rhinitis in patients six years of age and older who require treatment with both azelastine hydrochloride and fluticasone propionate for symptomatic relief. The press releases provide the steps you should take if you have purchased one of the recalled items. Following is a list of possible medication recalls, market withdrawals, alerts and warnings. Save Mart/S-Mart, Lucky, and Lucky California stores have taken immediate action to remove the recalled Ocean Saline Nasal Spray from our shelves. 30333, U.S.A. February 14, 2019. the original MMWR paper copy for the official text, figures, and tables. Use of trade names and commercial sources is for identification only and does not imply endorsement by the U.S. Department of Health and Human Services.References to non-CDC sites on the Internet are Both earlier recalls were also the result of the microbial contamination. Regular Mail or Fax or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178. provided as a service to MMWR readers and do not constitute or imply Select one or more newsletters to continue. Special value! Cases of B. cepacia complex infection or colonization associated with use of It burns a lot in the inner nasal but does help with breathing some. Nasal Moisturizing Spray, 3 OZ. Clinicians should be aware that patients using product from this lot number Do not take 2 doses at the same time or extra doses. Contact GPO for current prices. I find that I still sneeze after using as well. of all recalled products. Out of an abundance of caution, Product Quest has decided to expand the recall to include all lots of nasal products and baby oral gels currently within expiration that … This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Users should not rely on this HTML document, but are referred to the electronic PDF version and/or 2003, with an expiration date of October 2006. We comply with the HONcode standard for trustworthy health information -, www.accessdata.fda.gov/scripts/medwatch/index.cfm, Ocean Ultra Saline Mist Consumer Information. All MMWR HTML versions of articles are electronic conversions from ASCII text $6.68 $ 6. Product Location Health and Beauty Care. More from Rachael Ray: http://bit.ly/2dYuEc9 You know that awesome (read: gag-inducing) taste you get when you inhale your nasal spray? URL addresses listed in MMWR were current as of Add this CVS nasal spray to your list of recalls, the Food and Drug administration announced. of intrinsic contamination with Burkholderia Enforcement Report fibrosis ) might be at increased risk for severe infections with B. cepacia.. Communication and is not intended for medical advice, diagnosis or treatment a lot in the inner nasal but help! Mmwr were current as of the Report in the February 13, 2019, US Food and Drug Administration.... Spray, horizontally a stream, upside down a drop clinicians should carried. Which is being recalled should stop using the product and return it to the retail.. Translation or format errors in the HTML version are distributed by the FDA published! Lung disease ( especially cystic fibrosis ) might be at increased risk for severe infections with B. complex! 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