Pharma & Life Sciences

Apo-Fluoxetine Recalled Due to Impurities Out of Specification

Health Canada has issued a Type III health product recall for Apo-Fluoxetine 10mg and 20mg capsules by Apotex Inc. due to impurities being out of specification and out of trend. The recall affects retailer-level distribution. Affected lots include VM4608, VM4612 (20mg) and VM4598 (10mg). Patients with affected product should verify their medication and consult healthcare providers before making any changes to their treatment.

Stryker InZone Detachment System Type II Recall - Battery Drain

Health Canada issued a Type II recall for Stryker Neurovascular's InZone Detachment System. Certain device lots may experience premature battery drain, causing devices to fail to power on, display faint indicators, or be unable to detach coils as intended. Healthcare providers should contact Stryker Neurovascular at 47900 Bayside Parkway, Fremont, CA 94538 to verify affected lot numbers and obtain additional information.

Cardinal Health Angiography Pack and Catheterization Packs Recalled

Health Canada has issued a Type I recall for Cardinal Health Angiography Pack and Catheterization Pack products. The recall affects model numbers SCV30COP18, SCV30COPBN, SCV30COPBO, and SAN30LHTHC. The issue stems from Namic Angiographic Rotating Adaptor (RA) Control Syringes included in these products, which may unwind during use and cause disconnection. Healthcare providers should immediately identify and stop using affected products and contact Cardinal Health for replacement or additional information.

QuickVue Dipstick Strep A Test Recalled - False Positive Results

Health Canada issued a Type II medical device recall for the QuickVue Dipstick Strep A Test (catalog 20125) manufactured by Quidel Corporation due to false positive results. Affected lots include 709509, 709487, 709503, 709684, and 233275. False positives may include faint pink lines as well as pink-to-red test lines. Healthcare providers using these tests should stop using affected lots and contact the manufacturer.

USDA Removes 48-Hour Pre-Export Examination Requirement for Horse Imports

USDA-APHIS has removed the requirement that horses imported to the United States be accompanied by documentation of pre-export examination within 48 hours of departure from the port of embarkation, endorsed by a salaried veterinary medical officer. The agency determined that logistical barriers prevented affected parties from meeting this requirement as written. The final rule, effective May 11, 2026, removes § 93.314(a)(5) while retaining other horse import regulations including port-of-entry inspections and quarantine protocols.

CMS Proposes CJR Model National Expansion to All Hospitals

CMS announced a proposed rule to expand the Comprehensive Care for Joint Replacement (CJR-X) Model nationwide through the FY2027 Hospital IPPS and LTCH PPS proposed rule. Beginning October 1, 2027, the model would be mandatory for most hospitals, making it the first nationwide test of an episode-based payment model for joint replacements. The model holds hospitals responsible for Medicare spending on joint replacement surgery, hospital stay, and 90 days of post-acute recovery care.

Proposes Faster Drug Prior Authorization Decisions with 24-Hour Urgent Deadline

CMS proposes a rule establishing mandatory prior authorization decision deadlines for drugs: 24 hours for urgent requests and 72 hours for standard requests. The rule would expand electronic prior authorization requirements to include drugs under Medicare Advantage, Medicaid, CHIP, Qualified Health Plans, and FF-SHOP. Impacted payers would be required to publicly report prior authorization metrics including approval rates, denial rates, appeal outcomes, and decision timeframes.

2026 CMS Interoperability Standards and Prior Authorization for Drugs Proposed Rule

CMS has released the 2026 CMS Interoperability Standards and Prior Authorization for Drugs proposed rule (CMS-0062-P), which would extend electronic prior authorization requirements to cover drugs for Medicare Advantage organizations, state Medicaid and CHIP fee-for-service programs, Medicaid managed care plans, CHIP managed care entities, and Qualified Health Plan issuers. The rule also proposes adding small group market QHP issuers on the FF-SHOP as impacted payers and would require impacted payers to adopt specific HL7 FHIR standards for electronic prior authorization transactions under HIPAA.

FY 2027 Medicare Hospital Inpatient and Long-Term Care Payment Rates Proposed Rule

CMS issued a proposed rule on April 10, 2026, updating Medicare payment policies and rates for inpatient hospitals and long-term care hospitals for FY 2027. The proposed rule would expand the Comprehensive Care for Joint Replacement (CJR-X) model nationwide, covering hip, knee, and ankle replacements in inpatient and outpatient settings, effective October 1, 2027. The rule also includes proposed changes to Organ Acquisition and Reimbursement Appeals policies.

CMS-1849-P Proposed Rule - Public Comment Deadline June 9

CMS published a proposed rule (CMS-1849-P) soliciting public comments on changes to Medicare and Medicaid program requirements. The comment deadline is June 9. Healthcare providers, accountable care organizations, and other stakeholders affected by CMS regulations should review the proposal and prepare comments.