As recalls of ranitidine-containing drugs in the US due to nitrosamine contamination continue, the marketer of Zantac, the leading OTC antacid brand with the ingredient, says it’s not clear whether the product eventually will relaunch.
Ranitidine’s US Future In Limbo As Tests Continue; ‘Glow-Boosting’ Mask Also Among Recent Recalls
Zantac marketer Sanofi says it’s unclear whether the product eventually will relaunch. In other recent consumer health and beauty recalls in US, a vitamin C-containing face mask is recalled following a “spike in complaints” about skin irritation and the insides of tubes of sodium chloride ophthalmic ointments made for Walgreens and CVS were found with materials used to make the containers.
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Kyle Diamantas was a partner with the Jones Day firm when he was tabbed as acting deputy commissioner to lead the FDA’s Human Foods Program, established in the agency’s reorganization which became effective in October.
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Streamlined process for reporting problems is key piece of “unified Human Foods Program” which officially launched on 1 October, as Commissioner Robert Califf says, “a new model for field operations and other modernization efforts.”
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Brands also making market moves as lawmakers consider legislation instructing Transportation Security Administration to provide guidance to minimize risk for contamination of baby formula and related pediatric nutritional products.
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Green Pharmaceuticals’ SnoreStop Nasal Spray, previously marketed as “NasoSpray,” still is available even though agency officials on multiple occasions for a month recommended a recall after an April inspection found “gross microbial contamination” in one lot.
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FDA says “extension affords covered entities the additional time necessary to ensure complete coordination across the supply chain in order to fully implement the final rule’s requirements—ultimately providing FDA and consumers with greater transparency and food safety.”
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HBW Insight speaks to AESGP director general Jurate Švarcaite about what's on the agenda for the upcoming 61st AESGP Annual Meeting, which will take place in Warsaw, Poland, between 2-4 June. Highlights include the role of prevention in self-care, discussions about how regulators will ensure the competitiveness of European industry on the world stage and incoming changes to sustainability legislation.
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CRN petition argues against general preclusion while NPA petition addressed specifically FDA’s wielding of the provision to prohibit the use of NMN supplements available in US. “FDA has acknowledged that they really can't answer one without answering. The two are inextricably linked,” says CRN CEO Steve Mister.