Its unclear why that happened, but the FDA hasnt issued a statement regarding this possible judgment lapse. (51)(52). (16), 44,000 pounds (equivalent to approximately 548,000 eight-ounce bottles) of specialty infant formulas Nestl Health Science Alfamino and Alfamino Junior arrived at the Louisville International Airport from Switzerland. Their first shipment will be Aptamil First Infant Milk Stage 1 (formula for healthy babies). (53), Possible health risks due to incorrect labels (the product is not intended for use as infant formula) (54), Similac TummiCare One Infant Formula Recall (Philippines), Abbott recalled these products for differences in the preparation scoop size and the label instructions. The baby had consumed Similac PM 60/40 from this lot. Similac infant formula will continue to be produced in alternative product sizes and formats for delivery to retail locations, in addition to increased production throughout our global manufacturing network. Theyre now investigating the circumstances of the babys death. Rakeen Mabud, the groups chief economist, pointed out that instead of improving its plant and making productive investments, Abbott chose to prioritize its shareholders. (8), After a three-week shutdown following massive floods in the area, the Abbott plant in Sturgis, Michigan, has finally reopened again on July 1, 2022. (31). Falsified records about several safety and quality concerns, including signing verifications without adequate knowledge, testing of seals, shipping products with fill weights lower than whats on the label, failure to maintain accurate maintenance records, etc. (35), Republican House representatives filed a counter bill they call the Babies Need More Formula Now Act which aims to obtain formulas from overseas sources. Abbott conducts extensive quality checks on each completed batch of infant formula, including microbiological analysis prior to release. Authorities are now investigating after Cronobacter was found to have possibly contributed to the death of one of the babies. (1). Cronobacter infection can be deadly, especially to newborns. The shutdown came after severe thunderstorms hit Michigan, leading to power outages and flood damage. Some might feel more secure choosing a well-known brand name. According to the hospital spokesperson, the kids ranged from babies to older children. This recall equates to less than one day's worth of the total number of ounces of infant formula fed in the U.S. and is not expected to impact the overall U.S. infant formula supply. Similac recalls several powdered formulas for possible contamination that can cause Cronobacter sakazakii and Salmonella Newport infection. Additionally, as part of Abbott's quality processes, we conduct routine testing forCronobacter sakazakiiand other pathogensin our manufacturing facilities. Additionally,recently tested retained product samples of Similac PM 60/40 Lot # 27032K80 (can) / Lot #27032K800 (case) were negative forCronobacter. Abbott is initiating a proactive, voluntary recall of certain lots of 2 fluid ounce/59 milliliter bottles of Ready-to-Feed liquid products for infants and children, including the brands SimilacPro-Total ComfortTM, Similac360 Total Care, Similac 360 Total Care Sensitive, SimilacSpecial Care24, Similac Stage 1, SimilacNeoSure, Similac Water (Sterilized) and Pedialyte Electrolyte Solution. Dr. Mark Corkins, a pediatric gastroenterologist at Le Bonheur Childrens Hospital in Memphis, Tennessee, revealed that he admitted two patients because their specialty formula is out of stock. The company clarified that these products are only available in limited quantities because production hasnt resumed at the Sturgis facility. These two shipments of Bubs amounted to 380,000 lbs equivalent to approximately 4 million eight-ounce bottles. Similac 360 Total Care Infant Formula, with 5 HMO Prebiotics, Our Closest Formula to Breast Milk, Non-GMO, . Many parents are closely monitoring infant formula and. (6), In response, deputy commissioner Frank Yiannas of the FDAs Office of Food Policy and Response submitted his resignation, effective February 24. Bing Guan/Reuters (32), The products originated from Zurich, Switzerland, and were trucked to Germany. (37). Prevent fake or fraudulent products from reaching store shelves. Once they get the FDAs go-signal, Abbott will return to EleCare production before restarting Similac and other formula lines. Why did it take four months to pull this formula off store shelves? Priority will be given to worst-hit regions, a Biden administration official said. I am deeply concerned about the practices at this Abbott facility and their apparent failure to implement and enforce internal controls at this facility. (56), The Similac recall involved dozens of different lots and products. The whistleblower alleged that Abbott Nutrition: (48), The whistleblower claims that this report was submitted to the FDA in October 2021, several months before the deaths of the babies and the February 2022 recall. A thorough review of all available data indicates that the infant formula produced at our Sturgis facility is not likely the source of infection in the reported cases and that there was not an outbreak caused by products from the facility. This can result in spoilage. It also called for the appointment of a strong leader and the reorganization of the FDAs food program. Abbott is voluntarily recalling these products after four consumer complaints related toCronobacter sakazakiiorSalmonellaNewport in infants who had consumed powder infant formula manufactured in this facility. CNN Abbott Labs said Friday that it is recalling certain lots of 2 fluid ounce/59 milliliter bottles of Ready-to-Feed liquid formula for infants and children due to a problem with the bottle caps. Similac powdered baby formula with an expiration date on or after April 1, 2022, and a code with first two digits of 22 through 37 and containing K8, SH or Z2 are part of a voluntary recall by its manufacturer, Abbott Nutrition. The other reports were made from Ohio and Texas in the following months. (46), Retailers like Target, CVS, and Walmart have since put a cap on the number of formula packs that consumers can buy online and from their stores. This recall equates to less than one day's worth of the total number of ounces of infant formula fed in the U.S. and is not expected to impact the overall U.S. infant formula supply. Photo: Stefani Reynolds / AFP via Getty Images. Call your pediatrician or doctor if your child shows signs of medical issues (such as stomach upset) from drinking the recalled product. So, Abbott includes this specialty product in the items being released along with these metabolic products: (47), Abbott assures consumers that these products have been tested, werent included in the recall, and comply with all the product release requirements before distribution. during the first recall, then Similac PM 60/40 in the second recall. As of May 8, 2022, market research company Datasembly estimates that 43% of the top-selling formula brands are out of stock. A review of the firms internal records also indicate environmental contamination with Cronobacter sakazakii and the firms destruction of product due to the presence of Cronobacter. (2), Cronobacter can cause severe, life-threatening infections such as sepsis or meningitis (inflammation of the membranes protecting the brain and spine), according to the CDC (Centers For Disease Control And Prevention). Similac is among the most popular formula brands, but is it a healthy option for your baby? While Abbott's testing of distributed product detected no pathogens, we are taking action by recalling the powder formula manufactured in this facility with an expiration of April 1, 2022, or later. Theyre doing it to fulfill the FDAs request. (2)(3). Similac Formula Recall Washington WIC - Temporary Choices for Infant Formula November 1 , 2022 1 Similac Formula Recall - November 1, 2022 . (28), Also, she believes that restrictions should be imposed on companies that receive federal funding or in Abbotts case, companies whose largest customers are federal programs such as the WIC. This case is under investigation, and at this time the cause of the infantsCronobacter sakazakiiinfection has not been determined. (56), Call 800-986-8850 or visit similac.com/recall (the companys website for recalls), Similac Go & Grow Milk Early Shield Powder, When we identified this, we did extensive testing of every product on the (factory) line, and more than 99.8 percent of the product was negative for beetle contamination, , said Abbott spokeswoman Melissa Brotz. (61), Similac Special Care Ready-to-Feed Premature Infant Formula Powder with Iron (2-ounce bottles), Is There A Recall On Similac Alimentum? The White House recently announced Operation Fly Formulas tenth flight to Fort Worth, Texas from Mexico, which will bring approximately 1 million pounds (equivalent to around 16 million 8-oz bottles) of Gerber Good Start Gentle infant formula. The shipment was taken to the Nestle distribution center about a mile away for standard quality control checks. Contains no artificial growth hormones and is non-GMO. 02.28.2022 UPDATE: Abbott is voluntarily recalling one lot of Similac PM 60/40 (Lot #27032K80 (can) / Lot # 27032K800 (case)) manufactured in Sturgis, Michigan. For many of these kids, finding the right formula can be a long, complicated process to make sure that it can meet their nutritional needs while also ensuring it wont trigger a potentially dangerous reaction, including dehydration or diarrhea. Recalls, Market Withdrawals, & Safety Alerts, Recalls, Market Withdrawals and Safety Alerts, Recalls, Market Withdrawals, & Safety Alerts, Archive for Recalls, Market Withdrawals & Safety Alerts, Abbott Voluntarily Recalls Certain Lots of 2 Fl. At least two kids have been hospitalized in direct connection with the formula shortage. Experts point out that baby formula isnt subjected to the same high temperatures that other foods undergo to kill potentially deadly bacteria and other germs. Foster a culture of compliance to ensure they produce the highest quality baby formulas, Empower workers to identify and report issues that could compromise their products safety and quality. Contact the store or manufacturer for the refund or replacement process. The products included in the recall were distributed primarily to hospitals and to some doctors offices, distributors and retailers in the U.S., including Puerto Rico; one lot of products was sent to Barbados, Bermuda, Colombia, the Dominican Republic, Haiti, Jamaica, St. Croix and St. Thomas; and two lots were sent to Canada, Curacao, Panama, and Trinidad and Tobago. Abbott has informed the FDA of this new setback and announced that formula production will likely be delayed for a few weeks. The products included in the recall were manufactured at our Columbus, Ohio, manufacturing facility. Congressional leaders and various groups also want to hold the FDA accountable for whatever lapses or responsibilities it might have overlooked that led to the Abbott plant closure and baby formula shortage. (28), House Speaker Nancy Pelosi said that there might be a need for indictment after the nationwide baby formula shortage is resolved. Similac 360 Total Care * Infant Formula is made with an exclusive blend of 5 HMO prebiotics structurally identical to those in breast milk. For all feeding-related questions or questions about your childs health, contact a healthcare professional. (58), Abbott Laboratories Inc. assured affected customers that their tests showed only 0.16% of the recalled Similac products were contaminated. (5), Last month, an independent outside review requested by FDA Commissioner Robert Califf slammed the agencys response to the Similac food recall and the formula shortage. How many infants were fed contaminated formula during this time?, In a statement, Abbott Nutrition wrote that they: (50), Abbott claimed that they dismissed this former employee (the whistleblower) due to serious violations of the companys food safety policies. FDA Commissioner Dr. Robert Califf is the first administration official to face Congress in an investigation of the baby formula shortage. In response, Abbott reportedly told the committee that the first report came in September from Minnesota health officials. Aside from these two children, at least three babies have been hospitalized at the Medical University of South Carolina Shawn Jenkins Childrens Hospital in Charleston, South Carolina, due to intolerance after their parents or caregivers tried other formulas due to the shortage. Yes. More are expected to arrive on three more flights in the coming weeks. iPhone users should open in Safari. FDA does not endorse either the product or the company. (5)(43), After getting involved in the massive Similac recall in February 2022, Abbott Nutrition recently announced that it plans to reopen the Sturgis, Michigan plant in about two weeks. Abbott conducts extensive quality checks on each completed batch of infant formula, including microbiological analysis prior to release. Similac powdered baby formula with an expiration date on or after April 1, 2022, and a code with first two digits of 22 through 37 and containing K8, SH or Z2 are part of a voluntary recall by its . (13). (28), However, Abbott denies that the buyback program hurt their products safety. On February 18, Abbott brand powdered infant formula products sold across the country have been flagged and recalled by the CIFA as there is the possibility of Cronobacter sakazakii and . Abbott also reminds parents and caregivers that Cronobacter sakazakii can be commonly found in the environment and a variety of areas around the home. After the recall, however, they had to try other formula options but were unable to tolerate them, leading to dehydration. Democrats also proposed a $28 million emergency spending bill to supposedly boost the FDAs resources, including adding more staff. 83/ounce) Enfagrow Premium Powder Toddler Formula - 32oz . (62), Possible contamination with black polyvinyl chloride plastic particles (61), Similac Advance with Iron Formula Powder (12.9-ounce cans). The .gov means its official.Federal government websites often end in .gov or .mil. (32), Another shipment with 114 pallets of Gerber Good Start Extensive HA formula from the Netherlands is expected to arrive via the second flight of Operation Fly Formula. After President Joe Biden announced Operation Fly Formula, several shipments have arrived from across the world to help the US solve the formula shortage. Formulas still to arrive starting in June or July: The CFIA (Canadian Food Inspection Agency) warned consumers who bought from Shoppers Drug Mart to check their products after the retail pharmacy giant accidentally sold recalled baby formulas from Abbott due to an online error. (17). (41), Jennifer Crouse, the Clinical Nutrition Manager of Childrens Wisconsin, disclosed that several children have also been admitted to their hospital or treated at the ER. (20). Importantly, no distributed product has tested positive for the presence of either of these bacteria, and we continue to test. (42), Crouse added that there were also some parents who watered down the formula in hopes of stretching their supply. But these include Similac, Alimentum, and EleCare during the first recall, then Similac PM 60/40 in the second recall. Inspect domestic and international suppliers. If spoiled product is consumed, gastrointestinal symptoms such as diarrhea and vomiting may occur. 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