Walmart shrimp may have been exposed to radioactive material, FDA says
Health officials said in a news release that it is investigating reports of Cesium-137 (Cs-137) contamination in shipping containers and frozen shrimp products processed by an Indonesian company, PT. Bahari Makmur Sejati of Indonesia, also known as BMS Food.
Some of the raw frozen shrimp products processed by an Indonesian company are sold at Walmart stores in thirteen states, including Alabama, Arkansas, Florida, Georgia, Kentucky, Louisiana, Missouri, Mississippi, Ohio, Oklahoma, Pennsylvania, Texas and West Virginia, according to the FDA.
Among the products includes Walmart's "great value brand frozen shrimp," the health agency said.
"If you have recently purchased raw frozen shrimp from Walmart that matches this description, throw it away," the FDA said. "Do not eat or serve this product."
Health officials advised people to talk to their healthcare providers if they think they've been exposed to elevated levels of the contaminant.
PT. Bahari Makmur Sejati and Walmart did not immediately return requests for comment.
Cs-137 is the radioactive form of Cesium, "a soft, flexible, silvery-white metal that becomes liquid near room temperature" used for medical devices and gauges, according to the Environmental Protection Agency.
Repeated exposure to low doses of Cs-137 can increase the risk of cancer, "resulting from damage to DNA within living cells of the body," health officials said in their news release.
The FDA said that the U.S. Customs & Border Protection alerted the health agency to the detection of Cs-137 in shipping containers in Los Angeles, Houston, Savannah and Miami. It said that all containers and product that tested positive for Cs-137 were denied entry into the country.
Health officials also cautioned that it did not detect Cs-137 in any product above the current derived intervention levels for Cs-137, of 1200 Bq/kg.
However, the FDA said that "the level detected in the breaded shrimp sample could represent a potential health concern" if it is combined with radiation in the environment or from medical procedures.
This article was originally published on NBCNews.com
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Business Wire
24 minutes ago
- Business Wire
Rocket Pharmaceuticals Announces FDA Has Lifted the Clinical Hold on the Pivotal Phase 2 Trial of RP-A501 for the Treatment of Danon Disease
BUSINESS WIRE)-- Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT), a fully integrated, late-stage biotechnology company advancing a sustainable pipeline of genetic therapies for rare disorders with high unmet need, today announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on the Company's pivotal Phase 2 trial of RP-A501 for the treatment of Danon disease. The hold was lifted in under three months, underscoring the efficiency of the FDA's review process and Rocket's commitment to expeditiously optimize safety and resume the trial. In its correspondence, the FDA confirmed that Rocket satisfactorily addressed issues outlined in the clinical hold. The FDA authorized the pivotal study to resume first with a recalibrated dose of 3.8 x 10¹³ GC/kg of RP-A501 in three patients, treated sequentially with a minimum four-week interval between each treatment. This adjusted dose aligns with the lower range of administered doses that were associated with efficacy across multiple biomarkers, echocardiographic and clinical endpoints in the Phase 1 study, and has been determined as most likely to confer the safety and efficacy identified in the low-dose Phase 1 cohorts. In addition, Rocket will collaborate with investigators to implement an immunomodulatory regimen more closely reflecting that administered in the Phase 1 pediatric cohort. The revised regimen discontinues prophylactic use of a C3 complement inhibitor, while maintaining sirolimus, rituximab, and steroids. Additionally, the protocol will specify a lower threshold for administering a C5 inhibitor (eculizumab) in response to impending complement activation. To date, six patients with Danon disease have been treated in the Phase 2 study with RP-A501. Further updates about the Phase 2 study can be expected following review of data from the next three patients. 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Rocket's innovative multi-platform approach allows us to design the optimal gene therapy for each indication, creating potentially transformative options that enable people living with devastating rare diseases to experience long and full lives. Rocket's adeno-associated viral (AAV) vector-based cardiovascular portfolio includes a late-stage clinical program for Danon Disease, a devastating heart failure condition resulting in thickening of the heart, and an early-stage clinical program for PKP2-arrhythmogenic cardiomyopathy (ACM), a life-threatening heart failure disease causing ventricular arrhythmias and sudden cardiac death. Rocket has also received IND clearance for its AAV-based gene therapy for BAG3-associated dilated cardiomyopathy (DCM), a heart failure condition that causes enlarged ventricles. 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Rocket Cautionary Statement Regarding Forward-Looking Statements This press release contains forward-looking statements concerning Rocket's future expectations, plans and prospects that involve risks and uncertainties, as well as assumptions that, if they do not materialize or prove incorrect, could cause our results to differ materially from those expressed or implied by such forward-looking statements. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. All statements other than statements of historical facts contained in this release are forward-looking statements. You should not place reliance on these forward-looking statements, which often include words such as 'could,' 'believe,' 'expect,' 'anticipate,' 'intend,' 'plan,' 'will give,' 'estimate,' 'seek,' 'will,' 'may,' 'suggest' or similar terms, variations of such terms or the negative of those terms. These forward-looking statements include, but are not limited to, statements concerning expectations regarding the safety and effectiveness of product candidates that Rocket is developing to treat Fanconi Anemia (FA), Leukocyte Adhesion Deficiency-I (LAD-I), Pyruvate Kinase Deficiency (PKD), Danon Disease (DD) and other diseases, the expected timing and data readouts of Rocket's ongoing and planned clinical trials, the expected timing and outcome of Rocket's regulatory interactions and planned submissions, including the timing and outcome of the FDA's review of the additional CMC information that Rocket will provide in response to the FDA's request, the safety, effectiveness and timing of pre-clinical studies and clinical trials, Rocket's ability to establish key collaborations and vendor relationships for its product candidates, Rocket's ability to develop sales and marketing capabilities or enter into agreements with third parties to sell and market its product candidates, Rocket's ability to expand its pipeline to target additional indications that are compatible with its gene therapy technologies, Rocket's ability to transition to a commercial stage pharmaceutical company, and Rocket's expectation that its cash, cash equivalents and investments will be sufficient to fund its operations into the second quarter of 2027. Although Rocket believes that the expectations reflected in the forward-looking statements are reasonable, Rocket cannot guarantee such outcomes. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including, without limitation, Rocket's dependence on third parties for development, manufacture, marketing, sales and distribution of product candidates, the outcome of litigation, unexpected expenditures, Rocket's competitors' activities, including decisions as to the timing of competing product launches, pricing and discounting, Rocket's ability to develop, acquire and advance product candidates into, enroll a sufficient number of patients into, and successfully complete, clinical studies, the integration of new executive team members and the effectiveness of the newly configured corporate leadership team, Rocket's ability to acquire additional businesses, form strategic alliances or create joint ventures and its ability to realize the benefit of such acquisitions, alliances or joint ventures, Rocket's ability to obtain and enforce patents to protect its product candidates, and its ability to successfully defend against unforeseen third-party infringement claims, as well as those risks more fully discussed in the section entitled 'Risk Factors' in Rocket's Annual Report on Form 10-K for the year ended December 31, 2024, filed February 27, 2025 with the SEC and subsequent filings with the SEC including our Quarterly Reports on Form 10-Q. Accordingly, you should not place undue reliance on these forward-looking statements. All such statements speak only as of the date made, and Rocket undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.


Newsweek
an hour ago
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CNBC
an hour ago
- CNBC
Walmart shrimp may have been exposed to radioactive material, FDA says
The Food and Drug Administration said Tuesday that the public should avoid eating certain frozen shrimp sold at Walmart due to concerns that the seafood may have been contaminated with radioactive material. Health officials said in a news release that it is investigating reports of Cesium-137 (Cs-137) contamination in shipping containers and frozen shrimp products processed by an Indonesian company, PT. Bahari Makmur Sejati of Indonesia, also known as BMS Food. Some of the raw frozen shrimp products processed by an Indonesian company are sold at Walmart stores in 13 states, including Alabama, Arkansas, Florida, Georgia, Kentucky, Louisiana, Missouri, Mississippi, Ohio, Oklahoma, Pennsylvania, Texas and West Virginia, according to the FDA. Among the products includes Walmart's "great value brand frozen shrimp," the health agency said. "If you have recently purchased raw frozen shrimp from Walmart that matches this description, throw it away," the FDA said. "Do not eat or serve this product." Health officials advised people to talk to their health care providers if they think they've been exposed to elevated levels of the contaminant. PT. Bahari Makmur Sejati and Walmart did not immediately return requests for comment. Cs-137 is the radioactive form of Cesium, "a soft, flexible, silvery-white metal that becomes liquid near room temperature" used for medical devices and gauges, according to the Environmental Protection Agency. Repeated exposure to low doses of Cs-137 can increase the risk of cancer, "resulting from damage to DNA within living cells of the body," health officials said in their news release. The FDA said that the U.S. Customs and Border Protection alerted the health agency to the detection of Cs-137 in shipping containers in Los Angeles, Houston, Miami and Savannah, Georgia. It said that all containers and products that tested positive for Cs-137 were denied entry into the country. Health officials also cautioned that it did not detect Cs-137 in any product above the current derived intervention levels for Cs-137, of 1200 Bq/kg. However, the FDA said that "the level detected in the breaded shrimp sample could represent a potential health concern" if it is combined with radiation in the environment or from medical procedures.