Protecting patient health and safety is our highest priority, and the FDA continues to investigate and take action against companies that place U.S. patients at risk. 7. Canned sardines in water 3.75 oz: $1. Cessation of Preparing, Packing or Holding FDA Regulated Articles for Distribution. "It could be as simple as touching someone's cheek or face," according to FDA medical advisor Arthur Simone, MD. You might think that the sharper the knife, the more dangerous it can be. Canned mackerel 10 oz: $1. Are Dollar Tree Vitamins Any Good - "if something is not a name brand, skip it, especially with skin care products, and. One of the items you canconsider purchasing at a dollar store is over-the-counter drugs, but only in circumstances where you are familiar with the brand and are certain said brand is reputable. It can also stand for a cardiac care unit, which provides specialized. Apparent bird droppings were observed on chocolate protein shakes and Vitamin C supplement drops and on the floor near the northeast side of the small food storage racks by the shipping area ((b)(4) and (b)(4), respectively). Multiple dock doors were observed to have gaps allowing for potential entry of pests into the facility. Many shopping experts steer consumers away from purchasing toys at the dollar store: "I wouldn't purchase toys at the dollar store. And you should be too, according to The Washington Post, which in 2019 pointed out that anything with an electrical cord that is off-brand is a risky purchase, particularly power strips and chargers, which are likely to be cheaply made and could damage whatever you plug into them. The inspection of your facility revealed serious violations of FDAs regulations for Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Foods under Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117). The letter details that although the company had limited manufacturing operations at their corporate headquarters, the violations that the agency identified at Dollar Trees foreign-based OTC drug supplier facilities caused products manufactured there to be adulterated under the Federal Food, Drug, and Cosmetic Act. ALWAYS EXERCISE YOUR OWN DUE DILIGENCE BEFORE PURCHASING ANY PRODUCT OR SERVICE. A meeting can be scheduled between you and the FDA to discuss the requirements. RSS Shipping doors (b)(4) and (b)(4) were observed to have approximately 2-inch gaps running the entirety of each side of the dock plates. The devices are adulterated within the meaning of section 501(a)(2)(A) of the Act [21 U.S.C. Products stored at your facility, including adulterated drug products, were shipped to 404 Family Dollar retail stores after being held in the above-mentioned conditions. If you have any questions, call Mason Vitamins at 888-860-8376, Monday through Friday, 9 a.m. to 5. Firstly, value-brand dollar store batteries could actually leak and damage your devices, according to consumer expert Andrea Woroch, via GOBankingRates. The U.S. Food and Drug Administration has issued a warning letter to Greenbrier International, Inc., doing business as Dollar Tree, for receiving over-the-counter (OTC) drugs produced by. Back in 1953, per the company's website, a man named k.r. One of the items you can consider purchasing at a dollar store is over-the-counter drugs, but only in circumstances where you are familiar with the brand and are certain said brand is reputable. Product Recalls Click on the questions below to find answers and help. A Dollar Tree representative emphasized that their third-party manufactured products are subject to stringent safety testing and that the OTC drugs in question are intended for topical use only. Several high blood pressure drugs have been recalled the past 3 years due to an unexpected impurity. 5. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction. YOU SHOULD ALWAYS CONSULT WITH YOUR PERSONAL PHYSICIAN REGARDING ANY PERSONAL HEALTH PROBLEM, AND YOU SHOULD ALWAYS CONSULT WITH YOUR FINANCIAL ADVISER REGARDING INVESTMENT DECISIONS. 1800 Family Dollar Pkwy The price will be appealing, but there's no knowing if these are quality products, and my guess is that they are not," shopping expertTrae Bodge told Mashed. We have reviewed your responses and we discuss your significant violations and your corrective actions below. Heavy buildup of dust and debris around and under pallets storing cosmetic products. In other words, dollar stores (via Fast Company). Between the dates of March 29, 2021 to September 17, 2021, your firm documented over 2300 rodent captures. Material Connection Disclosure Three bags on the lowest layer of the pallet also contained gnaw holes ranging from 2 inches to 4 inches in diameter. Shutterstock/New Africa. As always, we are cooperating with the U.S. Food and Drug Administration. The FDA requests that you include in subsequent responses any ongoing or future corrective actions your firm is implementing specific to these products. In addition to the rodent infestation, investigators documented the presence of birds in and around the animal foods. The following are examples of inadequate maintenance conditions that were observed: Gaps were found along the top of the compactor that is meant to create a seal between the compactor and the exterior wall of the facility. Canned tuna: $1. Each of the items referenced in the report are topical, and not ingestible, products, Randy Guiler, vice president, investor relations, Dollar Tree, Inc told Healthline in an emailed statement. Compare active ingredients to your favorite vitamin and you'll see little to no difference.Youll save a lot of money i can promise you that. So, your first order of business when purchasing hand sanitizer from a dollar store is making sure that what you're purchasing has such a label. Manufacturers that received these warning letters were placed on import alert, which are used to prevent potentially violative products from being imported into the U.S. market. According to firm management, the General Manager closed the ICC and breakroom in October 2021 because of complaints related to strong odors associated with dead rodents. Can the Fourteenth Amendment Be Used to Protect Human Life Before Birth. FDA conducted a review of your pest control records. And you can rely on those prices no matterwhatthe economy is doing (albeit with a few exceptions, buthere's why some things at dollar stores cost more than a dollar). According to internal emails reviewed during the inspection, your firm was contacted by stores as far back as December 8, 2020, sharing their observations of rodent activity in deliveries of food products from the distribution center. Epidemic refers to disease across a region, and pandemic refers to disease in many countries. Young Thug reportedly facing life in prison . Specifically, your firms failures at preventing, controlling, and mitigating an active rodent infestation were described under the human foods observations 1-2 above. One bird was caught in netting hung from the roof above pallets of breakfast cereals. The importation and distribution of drugs and other products from manufacturers that violate federal law is unacceptable, said Donald D. Ashley, director of the Office of Compliance in the FDAs Center for Drug Evaluation and Research. If you're using an SPF product that is past its prime, you may expose yourself to the sun, thinking you're protected when you're not. Specifically, the devices held at your distribution center were exposed to significant rodent infestation and rodent excreta pellets. The remote control for the trucks was prone to short circuiting, which can cause overheating, fire, and burn hazards, according to theConsumer Product Safety Commission. These conditions were also observed in all four corners and the center of the warehouse. Researchers from the California Department of Public Health discovered that between 2007 and 2016, almost 800 products marketed as OTC dietary supplements contained unlisted active ingredients that were either unsafe or unstudied. The products were distributed to Dollar Tree stores in Alabama, Arkansas, Louisiana, Mississippi, Missouri and Tennessee. 321(h)], these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body. In fact, some dollar store purchases might even be dangerous. An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts, FDA issues warning letter to Dollar Tree stores for receiving potentially unsafe drugs. FDA received your written responses to those observations on March 7; March 22; April 8; May 6; June 10; July 15; August 19; and September 30, 2022. Have you seen the cost of vitamins as the drug store, grocery store, and other big b. In fact, Dollar Tree andFamily Dollar had beenselling a number of hand sanitizers that were later recalled by the FDA for containing undeclared toxic chemicals, including methanol (via Dollar Tree), exposure to which can result in serious health effects or even death, with young children being most at risk, the FDA reports. The products were distributed to Dollar Tree stores in Alabama, Arkansas, Louisiana, Mississippi, Missouri and Tennessee. FDA DISCLOSURE: THE STATEMENTS, ARTICLES, AND PRODUCTS FEATURED IN HEADLINE HEALTH EMAILS AND AT HEADLINEHEALTH.COM HAVE NOT BEEN EVALUATED BY THE FOOD AND DRUG ADMINISTRATION. In addition to the bird droppings, a dead bird was observed caught in bird netting overtop of this area. In addition, inadequate maintenance to parts of the facility allowed for potential pest entry and harborage areas within the facility. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. In this case, Dollar Tree has the ultimate responsibility to ensure that it does not sell potentially unsafe drugs and other FDA-regulated products to Americans. The warning letters sent to the contract manufacturers used by Dollar Tree show a pattern of serious violations of the law, such as not testing raw materials or finished drugs for pathogens and quality. The discount . These observations included, but are not limited to: o Multiple dead rodents found near slots (b)(4) and #(b)(4). And by the way, this is not the only waydollar stores could be harmful to the communities they are trying to serve. However, many consumers have been and remain wary of BPA, according to anFDA report. The .gov means its official.Federal government websites often end in .gov or .mil. They're all related to the Family Dollar rat-related recall from mid-February. Additionally, evidence of rodent contamination directly to devices was observed. We observed significant rodent activity throughout the facility. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. If it doesn't, it's a pretty good indication that the manufacturer is willing to cut corners to save money. Throughout the inspection, piles of food next to or spilling out of the large open-top dumpsters located on the west side of the shipping dock. You did not take effective measures to exclude pests from your holding areas and to protect against contamination of food on the premises by pests as required by 21 CFR 117.35(c). ", Dollar Store Purchases That Might Be Dangerous, here's why some things at dollar stores cost more than a dollar, one of the reasons dollar stores make so much money, dollar stores could be harmful to the communities they are trying to serve, sneaky ways dollar stores might try to scam you, reasons why dollar store food is so cheap, not all hand sanitizers are created equal, tonight's leftovers for tomorrow's dinner, what you're storing tonight's leftovers in, things that are important to know before having a baby, James Humbert of the FDA's Office of Regulatory Affairs. But therein lies the rub. July 25, 2022 - Smyrna, TN, Vi-Jon, LLC is expanding its voluntary recall to include all lots of all flavors of Magnesium Citrate Saline Laxative Oral Solution within expiry to the consumer level. Since it's hard to know how old a particular skincare product bought from overstock liquidations might be, Bodge says she would "question" whether skincare products on dollar store shelves are worth buying, especially when it comes to sun protection. Digital Millennium Copyright Act (DMCA). Specifically, on February 1, 2022, apparent bird droppings covering an area of flooring 1.5 foot wide, and 3 feet long were observed by the northwest end of aisle (b)(4). Consumer expert Andrea Woroch apparently agrees, but based on a slightly different risk factor. The Consumer Product Safety Commission (CPSC) announced on April 14 that the company had issued a recall of more than a million Crafter's Square Glue Guns sold at both Dollar Tree and Family Dollar stores across the U.S. through Feb. 2022. Of particular concern, the Warning Letter detailed FDA evidence that Dollar Tree, parent company of Family Dollar, distributed drugs that were manufactured at a facility where rodent feces were found throughout.2 In light of these two separate incidents involving significant rodent infestations in your supply chain, we recommend that Family Dollar take steps to evaluate whether there are additional issues with rodent infestation in your drug supply chain. The warning letter details Dollar Trees receipt of adulterated drugs from manufacturers that received FDA warning letters in 2018. Your firm began the decommissioning of a conveyor system. Specifically, our investigators observed evidence of rodent activity, including live rodents, dead rodents in various states of decay, rodent excreta pellets (REPs) in numbers too numerous to count (TNTC), gnaw marks in food and food packaging, nesting material, and odors indicative of rodent infestation throughout the entire facility including areas where human food, including dietary supplements, are routinely stored. These conditions were observed in the center of each of the (b)(4) food areas of your warehouse, consisting of aisles (b)(4) and (b)(4). In addition tofoods you should never buy therebecause they probably aren't the bargain you think they are or because they simply taste bad, there are some foods that could be downright dangerous to purchase at dollar stores. When you can get your basic vitamins at the Dollar Tree. The compactor has a (b)(4) door for access from the inside of the firm that is left open during business hours. All of the products recommended above are sourced from wild-caught fish which we believe to be healthier than farmed fish. That drew my attention.. Piled-up trash extending approximately 2 feet out from the walls of the facility. The FDA lab determined that the submitted product had urine stains and rodent hairs, the packaging had rodent gnawings and urine stains, and the REPs were determined to be of rodent origin. Program Division Director . You can find the Act and FDA regulations through links on the FDAs home page at http://www.fda.gov. Your facility holds and distributes various human foods, including dietary supplements; animal foods; cosmetics; over-the-counter drugs (OTC drugs); and devices. In addition, some dollar store inventory is made of other stores' stock liquidations, which sometimes means expired foods and over-the-counter drugs, items that may have been subject to recall, and merchandise that is simply of poor quality (via Washington Post). . Advertise with Headline Health One of those is canned foods from dented cans. If you can't find your specific question or need more help, click on the " I Need More Help " button at the bottom of the page to contact us for more assistance. A full list of recall products can be found below: # The quality is never there and could be potentially harmful if the toy breaks and sharp edges are exposed," shopping expertTrae Bodge told Mashed. For example, throughout the inspection, FDA investigators observed the following conditions: Large amounts of trash (including food trash), wood from pallets, and debris were piled below dock doors and along the shipping and receiving area walls of the facility. One was caught in a snap trap zip tied to a metal beam next to dock door (b)(4) and the other was behind a metal beam against the outer wall. More specifically, receiving doors (b)(4) and (b)(4) had gaps up to 3 inches in length and 1 inch in height around the doors, and receiving doors (b)(4), (b)(4) and (b)(4) were observed to have gaps at least 2 inches in height and 6 inches in length. You'll also want to check the expiration date on any food you purchase at a dollar store, because dollar stores can and do sell expired foods. For example: On February 2, 2022, FDA investigators observed a pallet of Family Wellness Pregnancy Tests, lot W00101202, located in bay (b)(4) with numerous rodent excreta pellets on the top of and in between cases along with nesting material and fluorescing stains. The second was observed on the east side of the mezzanine level under part of the old conveyor system. These samples included human food products (samples 1124522, 1179824, and 1179931) and an animal food product (sample 1176277), product packaging, and a filth sample (sample 1176276). The company said anyone who may have bought a recalled item may return it to where it was purchased without a receipt. Dollar Tree received a warning letter from the FDA regarding products manufactured for them by foreign manufacturers. Privacy Policy o A dead bird below part of the old conveyor system on March 7, 2022. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration. This equipment became a harborage area for rodents as evidenced by the observation of a dead rodent that was seen in between the conveyor belts of the Upper West Side Belt and investigators noting a foul odor indicative of dead and decaying animals in another section of what would be the Upper Southside Belt.. The warning letter outlines multiple violations of current good manufacturing practices at contract manufacturers used to produce Dollar Trees Assured Brand OTC drugs as well as other drug products sold at Dollar Tree and Family Dollar stores. 351(a)(2)(B)] in that the building used in the holding of drug products was not maintained in a clean and sanitary condition and was infested by rodents and other vermin as required by 21 CFR 211.56(a). Further, we request your firm provides records demonstrating the effectiveness of your corrective actions taken to reduce the presence of rodents, and other pests, in your distribution warehouse, including records of ongoing rodent control activities, such as capture numbers and their locations in your subsequent responses. And some of these stores may have continued to sell such hand sanitizers even after they were recalled. According to Bodge, "freshness and quality can be questionable," so it's best to "proceed with caution.". Altaire Pharmaceuticals Inc. has recalled several types of over-the-counter and prescription eye drops and ointments due to a possibility sterility, A food manufacturer is voluntarily recalling several packages of vegetables due to a potential Listeria contamination. Crime - Sacto 911. Remediating violations of the Act will be necessary if Family Dollar, a successor, or an acquirer resumes operations related to FDA regulated articles at this site. And part of the dollar store business model is to open up exactly where they seem to be most needed, which is to say, neighborhoods where incomes tend to be low and few other shopping options exist that's actuallyone of the reasons dollar stores make so much money. And according toConsumer Reports, not only are there differences in the amount of energy in name-brand versus value-brand batteries, a Southeastern Louisiana University researcher also found that, more specifically, dollar store batteries are sold with less stored energy than name-brand batteries. "Skincare products need to be fresh in order to be effective," according to shopping expertTrae Bodge. Your written response should be sent to Chad J. Whitwell, Compliance Officer, U.S. Food and Drug Administration at the following email: Chad.Whitwell@fda.hhs.gov (preferred) or you may also mail a hard copy addressed to Chad J. Whitwell, Compliance Officer, U.S. Food and Drug Administration at 1201 Main St, Suite 7200, Dallas, TX 75202. Our experts continually monitor the health and wellness space, and we update our articles when new information becomes available. The problem, as Bodge explained toMashed, is that a dollar stores get some of their inventory from overstock liquidations, and that includes some skincare products. The United States Food and Drug Administration (FDA) inspected your facility, Family Dollar Distribution Inc., located at 1800 Family Dollar Parkway, West Memphis, AR 72301 from January 11, 2022 through February 11, 2022. 2. Fluorescing stains were observed in and around the packaging for spilled flour and popcorn. Sincerely, If you have these vitamins, throw them out or return them to the store for a full refund. Babies are at higher risk than adults when it comes to exposure to environmental toxins for a number of reasons, including simply by virtue of their smaller size, according to a 2020 research in the journalPediatric Annals. We acknowledge your decision to close the facility and cease distribution of all FDA regulated articles from the site. Infants, children, pregnant women, the elderly, and immunocompromised persons are at greatest risk for infection and are more likely to have severe symptoms. There are reasons why dollar store food is so cheap,and some of these are perfectly benign, including lower operating costs than many grocery stores or selling a lot of private label foods. The agency encourages health care professionals and consumers to report any adverse events to the FDAs MedWatch Adverse Event Reporting program: The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The .gov means its official.Federal government websites often end in .gov or .mil. 331(a), the introduction or delivery for introduction into interstate commerce of any food, drug, device, or cosmetic that is adulterated is a prohibited act. While investigators unstacked the pallet, two mice exited from gnawed-open product bags stacked on the bottom layer of the pallet and ran west under the north end of aisle (b)(4). The FDA inspections of these foreign facilities revealed significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals.. Subscribe to Headline Health Office of Human and Animal Food Operations Approximately 40 REPs on a pallet containing (b)(4) bundles of four 3.15-pound bags of Tender & Crunchy Combo cat food stored in rack location (b)(4) One of the 3.15-pound bags also contained a circular gnaw-hole approximately 1.5 inches in diameter. Food products purchased from Family Dollar retail stores located in Alabama, Arkansas, Louisiana, Mississippi, Missouri and Tennessee, Cosmetic products purchased from Family Dollar retail stores located in Alabama, Arkansas, Louisiana, Mississippi, Missouri and Tennessee, including but not limited to skin and eye care products, baby oil, lipstick, shampoo, baby wipes, Dietary supplements purchased from Family Dollar retail stores located in Alabama, Arkansas, Louisiana, Mississippi, Missouri and Tennessee, including but not limited to vitamins, herbal and mineral supplements, Pet food and treats purchased from Family Dollar retail stores in Alabama, Arkansas, Louisiana, Mississippi, Missouri and Tennessee that are packaged in material other than glass or metal can, RESOURCES Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. The warning letter also details Dollar Trees use of contract manufacturers that also received warning letters for similar issues between 2016 and 2019. This recall comes after last months FDA warning to consumers to throw out products from Family Dollar stores in a number of categories, including human food, because of a severe rodent infestation in a distribution facility in Arkansas. That letter outlined multiple violations of U.S. manufacturing standards by drug manufacturers supplying over-the-counter medications sold at Dollar Tree and Family Dollar stores. Edmundo Garcia, Jr. Sure, 1997 is a while ago now, but anyone who bought one of those adapter plugs that were recalled by Dollar Tree that year for potential fire and shock hazards might stillbe wary of buying basically anything involving an electrical plug from a dollar. ET. Investigators documented signs of rodent gnawing, and nesting material associated with long term rodent presence throughout the facility where the devices were held. This is another item where you won't get much bang for your buck. Family Dollar is recalling more than 430 products including pain relievers and cough syrup because the products were not stored at the proper temperature. But others could make you think twice about buying groceries at a dollar store. Multiple bags of product were gnawed open, and product was spilling out of cases onto lower levels of the pallet. The. That's because some dollar stores have been known to stock over-the-counter medications produced outside of the U.S. by manufacturers that have been cited for violating food and drug laws, according to theU.S. Food and Drug Administration(FDA). Under section 201(h) of the Act, [21 U.S.C. You were aware of a rodent infestation at your facility beginning in 2020, and you continued to ship products, including drug products, to stores up until January 13, 2022 when fumigation of the facility occurred. Also,Consumer Reportsreported in 2019 that some studies actually linkBPA to various health issues, including infertility and certain cancers, and that a recent study indicates that the way the FDA and others have been measuring BPA could be vastly understating how much BPA is present in everyday products. When we have violations of this standard, there certainly should be an investigation as to why that happened and what steps are being taken to correct it, Glenn Hardesty, DO, emergency medicine physician, Texas Health Presbyterian Hospital Plano, told Healthline. Rats were climbing through the pallet in this rack location and climbing up rack scaffolding to reach upper levels. Contact Us 342(a)(4)] in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health. 25807G; and 30-count bottles of People's Choice Women's Daily Vitamins with Iron, lot Nos. You did not keep grounds around your plant in a condition that would protect against the contamination of food as required by 21 CFR 117.20(a). The site is secure. Your firm should investigate and determine the causes of any violations and take prompt actions to correct any violations and bring the products into compliance. Heres what you need to know about water quality in North America. (RTTNews) - Family Dollar, Inc., affiliated to Dollar Tree Inc., has recalled certain drug, device, cosmetic, and food products regulated by the U.S. Food and Drug . The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. Reports from your pest control company documented the capture of between 16 and 107 rodents for all months of 2020 and January June of 2021. "Whatever your complexion, it's important to use products that will help your skin and not damage it," the FDA wrote in 2016. Said anyone who may have bought a recalled item may return it to where it purchased. Preparing, Packing or Holding FDA Regulated articles from the FDA requests that you include in responses... Foreign facilities revealed significant violations of current good manufacturing practice ( CGMP ) regulations for finished pharmaceuticals long term presence..., throw them out or return them to the store for a full refund issues between 2016 and.. 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