Martinelli's recalls 170,000 apple juice bottles over toxic mold risk
California-based S. Martinelli & Co. has issued a voluntary recall of more than 170,000 bottles of its popular apple juice due to concerns over potential contamination with patulin, a toxic substance produced by certain molds that can grow on fruit.
The Watsonville (Santa Cruz County) juice company initiated the recall in March. The Food and Drug Administration classified it as a Class II recall last week, affecting 7,234 cases of 10-ounce glass bottles sold in 4-packs, each with a white metal screw-top lid.
The bottles in question were produced in December 2023 and have a best by date of Dec. 5, 2026. They are marked with UPC number 0 41244 04102 2.
No illnesses have been reported, and the company said all affected products have been removed from store shelves in 28 states, including California.
According to the FDA, patulin is a naturally occurring toxin that may cause nausea, vomiting and gastrointestinal issues. The Class II classification means the product could lead to temporary or medically reversible health effects, though the likelihood of serious harm is low.
'In 2024, the Food & Drug Administration (FDA) routine testing indicated that one lot of 10-ounce Martinelli's Apple Juice glass bottles (in 4-packs only) produced in December 2023 may contain elevated levels of Patulin,' the company said in a statement.
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Such information may be limited or incomplete, and ImmunityBio's statements should not be read to indicate that it has conducted a thorough inquiry into, or review of, all potentially available relevant information. Such statements reflect the current views of ImmunityBio with respect to future events and are subject to known and unknown risks, including business, regulatory, economic and competitive risks, uncertainties, contingencies and assumptions about ImmunityBio, including, without limitation, (i) risks and uncertainties regarding the FDA regulatory submission, filing and review process and the timing thereof, (ii) whether the RMAT designation will lead to an accelerated review or approval, of which there can be no assurance, (iii) risks and uncertainties regarding commercial launch execution, success and timing, (iv) risks and uncertainties regarding participation and enrollment and potential results from the expanded access clinical investigation program described herein, (v) whether clinical trials will result in registrational pathways and the risks, (vi) whether clinical trial data will be accepted by regulatory agencies, (vii) the ability of ImmunityBio to continue its planned preclinical and clinical development of its development programs through itself and/or its investigators, and the timing and success of any such continued preclinical and clinical development, patient enrollment and planned regulatory submissions, (viii) potential delays in product availability and regulatory approvals, (ix) ImmunityBio's ability to retain and hire key personnel, (x) ImmunityBio's ability to obtain additional financing to fund its operations and complete the development and commercialization of its various product candidates, (xi) potential product shortages or manufacturing disruptions that may impact the availability and timing of product, (xii) ImmunityBio's ability to successfully commercialize its approved product and product candidates, (xiii) ImmunityBio's ability to scale its manufacturing and commercial supply operations for its approved product and future approved products, and (xiv) ImmunityBio's ability to obtain, maintain, protect, and enforce patent protection and other proprietary rights for its product candidates and technologies. More details about these and other risks that may impact ImmunityBio's business are described under the heading "Risk Factors" in the Company's Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on March 3, 2025, and the Company's Form 10-Q filed with the SEC on May 12, 2025, and in subsequent filings made by ImmunityBio with the SEC, which are available on the SEC's website at ImmunityBio cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date hereof. View source version on Contacts ImmunityBio Contacts: Investors Hemanth Ramaprakash, PhD, MBA ImmunityBio, Inc. +1 Media Sarah Singleton ImmunityBio, Inc. +1 Sign in to access your portfolio
Yahoo
2 hours ago
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A 9-year-old girl died after a dental surgery. Now we know why
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It's not clear if Moreno had the congenital form of methemoglobinemia, meaning present at birth, or a form triggered by exposure to certain medications. The disorder leads to symptoms such as shortness of breath, fatigue and cyanosis, or bluish discoloration of the skin, said Dr. Michael Levine of UCLA Health. Read more: Pope meets with child protection advisory board as survivors call for zero tolerance of abuse "Sometimes people have a defect in that system and they get congenital methemoglobinemian as a result," said Dr. Gentry Wilkerson, associate professor at the University of Maryland School of Medicine who has authored a study on the condition and ways to treat it. "I's so rare, I would be shocked if I ever saw it in my career." The San Diego Police Department's child abuse unit announced in April that it was investigating the girl's death but the department said Friday it has ceased its investigation and closed the case, said Lt. Travis Easter. Dreamtime Dentistry, the Vista, Calif., facility where Moreno underwent surgery, responded to the medical examiner's report by saying the death was "not due to dosage but instead due to her rare but undiagnosed/undetected medical condition." The dentistry office also said there were no clear signs before the surgery that she had this condition. "A common cause of exposure that can lead to methemoglobinemia is dental procedures because one of the medicines that they'll give for patients that have dental pain is benzocaine," Wilkerson said. Benzocaine was not listed in the medical examiner's report as one of the medications administered to Moreno. Wilkerson said dental procedures are generally very safe. But in other cases, "it's a medication dose dependent effect where a person can take an excess of quantity or an excess amount of the drug and then subsequently develop methemoglobinemia," Levine said. Moreno was referred to Dreamtime Dentistry after complaining about a toothache four months prior, according to the autopsy reviewed by The Times. The dental office accepted the referral because it offered Moreno "treatment under general anesthesia due to her young age and acute situational anxiety," the facility stated. A day before her March 18 surgery, Moreno's autopsy said that she had a fever but her symptoms resolved after being given children's Tylenol. Representatives for Dreamtime Dentistry told The Times they were not aware of her fever and noted that Moreno's mother, "completed and signed a pre-operative check-in form indicating 'No' when asked if the patient was sick." The pre-op evaluation included a thorough review of Moreno's medical and dental history, assessment of vital signs, a physical examination including heart, lung sounds and airway evaluation, among other procedures, according to a statement from Dreamtime Dentistry. Read more: Commentary: A mother's plea to Trump: If you want to encourage a baby boom, give families a break "All medications were administered according to manufacturer guidelines based on Moreno's age and weight," according to the statement from the facility. Throughout the procedure, anesthesiologist Dr. Ryan Watkins observed Moreno and noted no complications, the dental office stated. Once the procedure was completed, the child was monitored in the facility's recovery area until she awoke with stable vital signs. After the procedure, she was discharged into the care of her mother and sent home, according to the County of San Diego Medical Examiner's Office. Moreno fell asleep on the car ride home, and when she arrived home she stayed asleep and was transitioned into her bed, according to the medical examiner's office. Her family checked on her throughout the day and called 911 when it was discovered later that she was unresponsive. First responders transported Moreno to Rady Children's Hospital while performing life saving measures. When the child arrived at the hospital medical staff assumed life saving measures to no avail and she was pronounced dead, according to the medical examiner. Sign up for Essential California for news, features and recommendations from the L.A. Times and beyond in your inbox six days a week. This story originally appeared in Los Angeles Times.
