March 03, 2022- The FDA finalized guidance to help companies quickly and effectively remove recalled products from the market. The guidance describes steps companies should take before a recall is necessary, to develop recall policies and procedures that include training, planning, and record-keeping to reduce the time a recalled product is on the market and, thus, limit the public’s exposure to risk. A recalling company may act on its own initiative, or the FDA may inform the company that a distributed product violates the law and recommends recalling it. The FDA has the authority to require recalls. Because recalls can affect the entire supply chain, including downstream suppliers, wholesalers, or vendors, the FDA recommends that companies develop recall procedures to inform their entire distribution chain quickly. As a result, consignees can rapidly identify affected lots and recall downstream products when necessary. @ https://www.fda.gov/news-events/press-announcements/fda-urges-companies-be-recall-ready-protect-public-health-part-final-guidance-voluntary-recalls?utm_medium=email&utm_source=govdelivery
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FDA issues guidance to help companies prepare to quickly and effectively remove violative products from the market.
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According to the FSA, Tesco (Welwyn Garden City, Hertfordshire) has recalled Tesco Hog Roast Style Pork with Apple Sauce from the British marketplace due to suspected Salmonella contamination. The recalled product is Tesco Hog Roast Style Pork with Apple Sauce (suitable for freezing), sold in 425 gram boxes with a use-by date of 06 January 2022, 09 January 2022, 15 January 2022, 17 January 2022, 6 February 2022, 8 March 2022 or 9 March 2022. @ https://www.food.gov.uk/news-alerts/alert/fsa-prin-12-2022
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As of February 28, CDC has announced one additional illness of Cronobacter sakazakii with exposure to powdered infant formula produced at Abbott Nutrition’s Sturgis, MI facility. Cronobacter infection may have been a contributing cause of death for this patient. In total, this investigation includes four reports of Cronobacter sakazakii infections in infants (three from FDA complaints and one from a CDC case finding) and one complaint of a Salmonella Newport infection in an infant. All five illnesses resulted in hospitalization, and Cronobacter may have contributed to death in two patients. The most recent patient was reported to have consumed Abbott Nutrition’s Similac PM 60/40 product with the lot code 27032K800 before Cronobacter sakazakii infection. FDA and CDC informed Abbott of these findings, and on February 28, 2022, Abbott Nutrition voluntarily recalled Similac PM 60/40 powdered infant formula with the lot code 27032K800. This is a specialty formula for certain infants who would benefit from lowered mineral intake and was not included in the previous recall. This lot of Similac PM 60/40 was distributed to the U.S. and Israel. In total, four infants in Minnesota (1), Ohio (2), and Texas (1) consumed formula produced at the Sturgis, Michigan, before they got sick. These infants consumed formula that included Similac Sensitive, Similac Pro-total Comfort, Similac Advance, and Similac PM 60/40. @ https://www.fda.gov/food/outbreaks-foodborne-illness/fda-investigation-cronobacter-and-salmonella-complaints-powdered-infant-formula-february-2022?utm_medium=email&utm_source=govdelivery
Do not use recalled Similac, Alimentum, or EleCare powdered infant formulas produced at Abbott Nutrition’s Sturgis, MI facility
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Politico reported that Sens. Patty Murray (D-Wash.) and Bob Casey (D-Pa.) yesterday demanded that Abbott Nutrition hand over information and documents related to the company’s recent recall and customer complaint. “It is completely unacceptable that manufacturing conditions allowed a contaminated product to reach babies, and that it took months for the company to act to warn parents and caregivers about this danger,” the senators wrote Abbott CEO and chair Robert Ford, citing POLITICO’s reporting. More reports from Texas and Maryland have been reported, and moms have flooded social media with complaints and unconfirmed anecdotes of infant illnesses and hospitalizations. Federal health officials have not publicly updated their case counts in more than a week. The timeline from the first illness to the sweeping recall spans months. The FDA initiated an inspection of the facility on Jan. 31. Inspectors found Cronobacter sakazakii in several environmental samples taken at the plant. The product was recalled on Feb. 17, about three weeks after the inspection kicked off. The FDA was actually in the plant for a routine inspection a few days after the first case was reported to FDA and CDC, but it doesn’t appear inspectors were looking for Cronobacter. The plant was not inspected in 2020, likely due to Covid-19. @ https://www.politico.com/news/2022/02/26/senators-demand-answers-from-abbott-on-infant-formula-recall-00012073