In addition to Sanofi, firms recalling OTC ranitidine products with documentation included in FDA's database updates through 9 January are Amneal Pharmaceuticals, Preferred Pharmaceuticals, which distributed products made by Amneal, and Granules India Ltd.
Sanofi's recall of OTC Zantac due to contamination of the active ingredient ranitidine with a potential carcinogenic is so widespread the US Food and Drug Administration's documentation of the firm's actions doesn't identify quantities of containers or packages but refers only to "all lots" of the products.
Information on some other firms' recalls for private label and store brand copies of OTC Zantac in 75- and 150-mg...
FDA testing of 95 benzoyl peroxide products due to concerns about elevated benzene detected by third-party testers found 90% with undetectable or extremely low benzene levels.
“The infant formula business is recovering and we've taken actions to simplify and consumerize our business, but there's a lot more work to do,” says CEO Patrick Lockwood-Taylor as Perrigo’s announced latest results.
Regenerative Processing replaces nozzle to prevent backflow for its Regener-Eyes drops but FDA warning states numerous questions about sterility at the firm’s plant and about its procedures and systems for preventing microbial contamination.
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.”
A US House bill would give the FDA $33.1m more in budget authority than requested by the Trump Administration for fiscal year 2026. The measure was sent to the full House Appropriations committee on a party-line vote.
The EU Council has introduced a key amendment to Article 51 (para 1, point e) of the new pharma directive: “A medicinal product shall be subject to medical prescription where it is an antimicrobial, unless intended for topical use.”
Marking most strident use of authorities it received in 2020 as part of an overhaul of monograph system, FDA publishes proposal to shift orally disintegrating formats to individual-dose packaging and a related proposal to minimize firms’ regulatory burden for making delivery format changes potential
