Recalls

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.

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.

The Therapeutic Goods Administration is advising companies to get up to speed with its new recall procedure, which is designed to improve the timeliness of recalls, alerts and corrections, and reduce regulatory burden for sponsors.

The Therapeutic Goods Administration is advising companies to get up to speed with its new recall procedure, which is designed to improve the timeliness of recalls, alerts and corrections, and reduce regulatory burden for sponsors.

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.

This week, Establishment Labs Holdings announced the FDA gave it premarket approval for Motiva breast implant, Cologuard lands FDA approval for Cologuard Plus and GE HealthCare gets FDA nod for a new imaging agent. The FDA announces another expansion for TAP into ophthalmology and radiology. The AAMI and CTA will join forces to develop standards for AI and ML-enabled health care products.  

Philips has issued a recall of various Trilogy ventilators due to safety issues that may affect their ability to properly function. The US FDA has designated the recall class I, its most serious.

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.”

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.

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.