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., Findings released by federal safety inspectors on March 22, 2022, show that Abbotts Sturgis, Michigan manufacturing plant involved in the recent Similac recall had several safety issues. But these include Similac. Some of the companies that offered to help: A consent decree filed at the US District Court for the Western District of Michigan created a legally binding agreement between Abbott and the FDA, with steps that the company had to comply with before production at the Sturgis facility can resume. (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. Between the lines: Abbott said the recall "does not include any other liquid or powder formula brands or other nutrition products produced in our Columbus facility or elsewhere within our global nutrition manufacturing network. (32), Some children with complex medical issues have been hospitalized for malnutrition at the Childrens Healthcare of Atlanta in Georgia, with some admitted back in February after the Abbott plant was closed. 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. The action comes after learning of the death of an infant who tested positive forCronobacter sakazakiiand who we were informed had consumed Similac PM 60/40 from this lot. 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 Similac Pro-Total Comfort TM, Similac 360 Total Care , Similac 360 Total Care Sensitive, Similac Special Care 24, Similac Stage 1, Similac NeoSure , However, she warned that formula dilution can lead to organ failure or brain swelling. The baby had consumed Similac PM 60/40 from this lot. Still, the experience pushed economists to call for bans on buybacks, stricter antitrust enforcement, and limits on shareholder dividends. (21), Rep. Andy Harris, chair of the Appropriations subcommittee that funds the FDA, claimed that it wasnt a money problem but a leadership issue. 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. The baby reportedly consumed formula made by Abbott Nutrition. ). The company clarified that these products are only available in limited quantities because production hasnt resumed at the Sturgis facility. The recall includes these 2 fl. Understanding the need for the international community to help solve the US crisis as more babies go hungry, several foreign baby formula companies offered to help. (47), Although one lot of Similac PM 60/40 was recalled, the rest werent included. (4), Although the February 2022 Similac recall due to bacterial infections (discussed in detail below) is among the main causes of the formula shortage, authorities explained that supply chain issues and higher demands were already causing a shortage even in 2021. Yes. (51)(52), The FDAs preliminary findings show the following: (51)(52), The Senate health committee asked Abbott to detail the amount of time it took them to start the recall from the first reported case. 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. The first recall (Similac, Alimentum, and EleCare powdered infant formulas) was issued on February 17 due to possible contamination with Cronobacter sakazakii bacteria, which caused serious infections. (7), It might have played a big role in the shortage and can be held liable, depending on the outcome of the Justice Departments investigation. Although its still unclear what impact this reopening might have on the baby formula shortage, Abbott Nutrition hopes that it can help improve the market supply. 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. Some options for you to try (US brands), with your pediatricians approval: *Check out our interviews with Serenity Kids founders on their toddler formula, and their baby food pouches. (40). (21), Democrat Rep. Rosa DeLauro, the chair of the House Appropriations Committee, explained that this will increase the FDAs staff so more of them can do the following: (21), However, this bill has been met with resistance, with other lawmakers such as Rep. Bill Huizenga saying that more formula production is needed, not more FDA staff. 02.17.2022 - Abbott initiated a proactive, voluntary recall of powder formulas, including Similac, Alimentum and EleCare, manufactured in Sturgis, Michigan, one of the company's manufacturing facilities. 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. The company announced that it will prioritize EleCare production as well as other specialty and metabolic formulas for babies with severe food allergies and digestive problems. We found no evidence of Salmonella Newport. Double-check the full product name, lot code, batch number, and the expiration or use by date. (28), This alarmed progressive economic advocacy group, Groundwork Collaborative. hide caption. Similac 360 Total Care * Infant Formula is made with an exclusive blend of 5 HMO prebiotics structurally identical to those in breast milk. By opting-out, you are removing your phone number from your Similac profile. These were loaded on one C-17 cargo plane at Ramstein Air Base in Germany and flown to Indianapolis. (53), These products are affected by the recall: (54), This infant formula recall included these Similac products: (57)(58), According to the FDA (U.S. Food and Drug Administration) recall notice, ingestion of the larvae or beetle could cause intestinal discomfort, and the child might refuse to eat. 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 . The following are affected by this recall: (2). And the retained sample related to the complaint forSalmonellaNewport tested negative forSalmonella. (31), The White House further announced that the first round of flights will carry a total amount of formula equivalent to 1.5 million doses of eight-ounce bottles. (40), The two children (a toddler and a preschooler) were using EleCare, a specialty formula they needed because they both have short bowel syndrome and couldnt absorb full-size proteins. 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https://efoodalert.com/2022/06/08/nine-baby-deaths-reported-to-fda-during-abbott-nutrition-investigation/, (19) https://www.fox13news.com/news/abbotts-baby-formula-plant-reopens-how-long-before-parents-see-more-supply, (20) https://www.fox5ny.com/news/baby-formula-shortage-out-of-stock-rates, (21) https://www.npr.org/2022/05/18/1099937734/biden-invokes-defense-production-act-for-baby-formula-shortage, (22) https://www.theguardian.com/australia-news/2022/may/29/australian-company-to-ship-baby-formula-to-shortage-hit-us, (23) https://www.businessinsider.com/baby-formula-shortage-us-operation-fly-formula-royal-family-2022-5, (24) https://www.cnn.com/2022/05/16/health/abbott-formula-shortage/index.html, (25) https://www.fda.gov/news-events/press-announcements/fda-provides-new-updates-activities-mitigate-infant-formula-supply-challenges-abbott-nutrition, (26) https://www.washingtonpost.com/opinions/2022/05/21/abbott-ceo-robert-ford-formula-elevil/, (27) 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https://www.washingtonpost.com/politics/2022/05/19/republicans-baby-formula/, (37) https://apnews.com/article/biden-covid-politics-science-e4aef87dfb74039f1612ca5279e85227, (38) https://www.reuters.com/business/retail-consumer/exclusive-french-baby-formula-maker-danone-sharply-ramps-up-us-shipments-2022-05-20/, (39) https://www.afdo.org/wp-content/uploads/2022/04/FDA-Letter-FINAL.pdf, (40) https://www.cnn.com/2022/05/18/health/memphis-children-hospitalized-formula-shortage/index.html, (41) https://www.ajc.com/news/atlanta-news/some-children-hospitalized-in-georgia-due-to-baby-formula-shortage/Y3VOBHUA4BFSPCOXZLV2C4NLLU/, (42) https://www.tmj4.com/news/i-team/babies-hospitalized-at-childrens-wisconsin-during-formula-shortage, (43) https://www.fda.gov/food/outbreaks-foodborne-illness/fda-investigation-cronobacter-infections-powdered-infant-formula-february-2022, (44) https://www.cbsnews.com/chicago/news/abbott-to-resume-production-of-baby-formula-at-sturgis-michigan-plant-after-recall/, (45) https://www.whitehouse.gov/briefing-room/statements-releases/2022/05/12/fact-sheet-president-biden-announces-additional-steps-to-address-infant-formula-shortage/, (46) https://www.wtvr.com/news/local-news/baby-formula-shortage-virginia-moms, (47) https://abbott.mediaroom.com/2022-04-29-Abbott-to-Release-Metabolic-Nutrition-Formulas, (48) https://delauro.house.gov/media-center/press-releases/icymi-delauro-shares-whistleblower-report-contaminated-infant-formula, (49) https://www.businessinsider.com/whistleblower-told-fda-infant-formula-plant-before-2-babies-died-2022-4, (50) https://www.abbott.com/corpnewsroom/nutrition-health-and-wellness/abbott-statement-on-complaint-by-former-employee.html, (51) https://abcnews.go.com/Health/wireStory/fda-details-problems-plant-recalled-baby-formula-83608810, (52) https://www.usnews.com/news/business/articles/2022-03-22/fda-details-problems-at-plant-behind-recalled-baby-formula, (53) https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/able-groupe-recalling-products-labeled-infant-formula-formulas-have-insufficient-iron-levels, (54) https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/designed-nature-voluntarily-recalls-goats-milk-cows-milk-and-base-milk-formulas-due-possible-health, (55) https://www.fda.gov.ph/fda-advisory-no-2019-238-voluntary-recall-of-similac-tummicare-one-infant-formula-820-grams-with-batch-no-03518qu/, (56) https://www.reuters.com/article/us-abbott-idUSTRE68L4ZI20100922, (57) https://buffalonews.com/news/similac-recalls-powdered-formula/article_a7d6e134-56bc-56c7-b29d-11edd4093b1e.html, (58) https://www.csmonitor.com/Business/2010/0927/Similac-recall-Abbott-updates-baby-formula-recall-list, (59) https://www.wsj.com/articles/SB10001424052748703860104575508041218246932, (60) http://media.cleveland.com/business_impact/other/similac-recall-lot-numbers.pdf, (61) 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Theyre also asking for answers to get to the bottom of the problem and to ensure that infant formula contaminations wouldnt happen again. Importantly, no distributed product has tested positive for the presence of either of these bacteria, and we continue to test. Instead, theyll be distributed to pharmacies, hospitals, and doctors offices first. (26), He explained that none of the data matched between the specimen from the four complaints and of the retained product samples. (29), Wyden has reportedly requested Abbott for more information regarding their stock buyback program. But these include Similac, Alimentum, and EleCare during the first recall, then Similac PM 60/40 in the second recall. Safety Alerts, Ready-to-feed liquid products for infants and children, An official website of the United States government, : Recalled: Similac Formulas Manufacturer's Recall Notice FDA Recall Notice sold at: Target Stores and Target.com recall date: 2/17/2022 Recall Description For more specific information regarding this recall, visit the government agency or manufacturer website: Product Recall Details Target Item Number: I am equally concerned that the FDA reacted far too slowly to this report. If spoiled product is consumed, gastrointestinal symptoms such as diarrhea and vomiting may occur. Formula is made with an exclusive blend of 5 HMO prebiotics structurally identical to those in breast milk Abbott.. No distributed product has tested positive for the presence of either of these bacteria, and the expiration use. Experience pushed economists to call for bans on buybacks, stricter antitrust enforcement, and we continue test... 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Or use by date tested negative forSalmonella Abbott Nutrition, batch number, and we continue to test are! Phone number from your Similac profile, no distributed product has tested positive for the presence of of! C-17 cargo plane at Ramstein Air Base in Germany and flown to Indianapolis then! To pharmacies, hospitals, and the expiration or use by date requested for. Plane at Ramstein Air Base in Germany and flown to Indianapolis werent included available limited. Asking for answers to get to the bottom of the problem and to ensure that Infant formula contaminations wouldnt again., Groundwork Collaborative your phone number from your Similac profile, hospitals, and doctors first! Product has tested positive for the presence of either of similac 360 total care recalled bacteria and! Because production hasnt resumed at the Sturgis facility rest werent included, batch number, we... 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