Pharma & Life Sciences

FDA Early Alert: Erbe USA Cryoprobes Rupture Risk

The FDA issued an Early Alert regarding Erbe USA Flexible Cryoprobes due to a risk of rupture during activation, potentially causing injuries and hearing loss. Erbe USA has recalled affected lots and recommended discontinuing use.

Worthy Crumb Pastry Co. Scones Recalled Due to Mould

The Canadian Food Inspection Agency has issued a recall for The Worthy Crumb Pastry Co. brand Cheddar and Chive Artisan Scones due to mould contamination. The product was distributed nationally, and consumers are advised not to use or distribute the affected product.

Venlafaxine XR Recall

Health Canada has issued a Type II recall for VENLAFAXINE XR 75mg capsules due to dissolution testing being out of specification. Retailers are instructed to remove the affected product from shelves. Consumers should consult a healthcare provider before discontinuing use.

Choco Lake Diamond Twist Chocolate Recalled Due to Aflatoxin Contamination

The Canadian Food Inspection Agency has issued a recall for Choco Lake Diamond Twist brand Milk Chocolate with Kunafa Pistachio Paste Flavor due to aflatoxin contamination. The recall affects products distributed in Ontario, with specific lot codes and expiry dates identified.

HHS OIG: Over $15 Million in Improper Medicare Payments for Non-Emergency Services

The HHS Office of Inspector General (OIG) reported that Medicare improperly paid physicians $922,524 and potentially $14.2 million to hospitals for services billed with emergency department procedure codes but rendered at non-emergency sites. The OIG recommends recovery of improper payments and improved claims processing controls.

Ketorolac Recalled Due to Weight Out of Specification

Health Canada has issued a Type II recall for Ketorolac (DIN 02245821) manufactured by AA Pharma Inc. due to weight being out of specification in affected lots VE3252 and VE3251. Retailers are instructed on the recall process and consumers are advised to consult healthcare providers.

Chikungunya Vaccine IXCHIQ: Risks for Frail Seniors 65+

Health Canada has issued updated safety information regarding the chikungunya vaccine IXCHIQ. Medically frail individuals aged 65 and older may be at increased risk of serious adverse reactions. Healthcare professionals are advised to carefully assess risks and benefits for this demographic.

Vicks Sinus Steam Inhaler Recall

Health Canada has issued a recall for the Vicks Sinus Steam Inhaler (VIH200CV1) because it was distributed without the required Medical Device License. Consumers are advised to retain the product and contact Kaz USA Inc. for further instructions.

FDA Draft Q&As on Biosimilar Development and BPCI Act

The FDA has issued a draft guidance document providing updated answers to common questions regarding biosimilar development and the Biologics Price Competition and Innovation Act (BPCI Act). This revision replaces a previous draft and focuses on specific Q&As related to the abbreviated licensure pathway for biological products.

FDA Guidance: Flavored ENDS Premarket Applications

The FDA has issued guidance to assist with premarket tobacco product applications (PMTAs) for flavored electronic nicotine delivery systems (ENDS). This guidance, intended to improve submission and review efficiency, focuses on considerations related to youth risk. The document is non-binding and aims to inform potential future rulemaking.