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Venlafaxine XR 75mg Capsule Recall Due to Out-of-Specification Dissolution

Health Canada has issued a Type II recall for VENLAFAXINE XR 75mg extended-release capsules (DIN 02339250, Lot 2505003230) manufactured by Pro-Doc Lté of Laval, Quebec. The affected batch was found to have dissolution out of specification, potentially affecting the drug's absorption and therapeutic efficacy. The recall is at the retailer level, and identification number RA-81722 has been assigned. Consumers in possession of this specific lot should consult their healthcare provider before discontinuing use.

Urgent Enforcement Pharmaceuticals
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Worthy Crumb Pastry Co. Scones Recalled Due to Mould

The Worthy Crumb Pastry Co. brand Cheddar and Chive Artisan Scones (660 g, UPC 7 70981 2421 32) have been recalled due to mould. Give and Go Prepared Foods Corp. initiated the Class 3 recall affecting 13 production codes (25346, 25353, 25354, 25356, 25357, 26008, 26009, 26014, 26022, 26023, 26029, 26030, 26037) with national retail distribution. The issue is classified as non-harmful microbial contamination (quality or spoilage).

Urgent Enforcement Food Safety
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Choco Lake Diamond Twist Milk Chocolate with Kunafa Pistachio Paste Flavor Recalled

Chocoland Canada (ABZ Wholesale Inc.) has recalled Choco Lake Diamond Twist brand Milk Chocolate with Kunafa Pistachio Paste Flavor (450 g, UPC 6 253361 248039, Code B.N.RM010825, PROD: AUG/12/2025, EXP: AUG/11/2026) due to contamination with aflatoxins. The recalled product was distributed through Ontario retail channels. Health Canada advises consumers not to use, sell, serve, or distribute the affected product.

Urgent Enforcement Food Safety
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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.

Priority review Notice Healthcare
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Vicks Sinus Steam Inhaler Sold Without Medical Device License in Canada

Health Canada issued a Type II recall for the Vicks Sinus Steam Inhaler (VIH200CV1) after discovering the device was distributed in Canada without the required Medical Device License (MDL) under Health Canada medical devices regulations. Lot number 17824 is affected. Consumers are requested to hold on to the product and contact Kaz USA Inc., a Helen of Troy Company consumer relations team at 1-800-827-6712 with any questions.

Urgent Enforcement Medical Devices
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Ketorolac Weight Out of Specification Recall AA Pharma Lots VE3252 VE3251

Health Canada has issued a Type II recall for KETOROLAC (Ketorolac Tromethamine 0.5% w/v Solution, DIN 02245821) due to weight being out of specification in affected lots VE3252 and VE3251. The recalling firm is AA Pharma Inc., located at 1165 Creditstone Road, Unit #1, Vaughan, Ontario, L4K 4N7. Healthcare providers are advised to consult with patients before discontinuing use of the affected product, and retailers at the retail level have been notified of the recall.

Urgent Enforcement Pharmaceuticals
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IXCHIQ Chikungunya Vaccine Risk for Frail Seniors 65+

Health Canada issued a safety alert on 2026-03-09 regarding IXCHIQ (chikungunya vaccine, live, attenuated), indicating that post-market data suggest individuals 65 years of age and older who are medically frail with multiple chronic medical conditions may be at an increased risk of serious and life-threatening adverse reactions following vaccination. The Canadian Product Monograph has been updated to reflect this safety information. Complications reported include malaise, decreased appetite, exacerbation of pre-existing diseases, confusional state, encephalopathy, encephalitis, falls, hospitalisation, and death.

Urgent Notice Pharmaceuticals
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New York Private Well PFAS Testing and Rebate Pilot Program

New York State has launched a pilot program offering free PFAS testing and rebates for water treatment systems or connection to public water for private well owners in six counties. The program aims to address PFAS contamination in drinking water and is funded with $1.5 million per county.

Priority review Notice Environmental Protection
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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.

Priority review Guidance Pharmaceuticals
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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.

Priority review Guidance Consumer Protection
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FDA Q&A on Biosimilar Development and BPCI Act

The FDA has reissued its final guidance on biosimilar development and the BPCI Act, solely to withdraw three specific Q&As (I.8, I.10, and I.19). The agency is continuing to evaluate other Q&As for potential updates.

Routine Guidance Pharmaceuticals