Policy Updates

4/4/22 — Following FDA reports about patient infections and possible contamination issues with reprocessed urological endoscopes, Karl Storz identified reprocessing failures following high-level disinfection. The company initiated a voluntary recall and issued an urgent field safety notice to instruct users to discontinue all high-level disinfection methods for all affected urological endoscopes and discontinue liquid chemical sterilization for most … Continued

4/4/22 — Best Brands Consumer Products is recalling two finished product lots of The Mandalorian Hand Sanitizer Ethyl Alcohol 68%, available in green and blue formulations and Mickey Mouse Hand Sanitizer Ethyl Alcohol 68% blue formulation because FDA testing found the presence of benzene in the Mandalorian Hand Sanitizer product and methanol in the Mickey Mouse … Continued

3/29/22 — The FDA authorized a manufacturing change for the Moderna COVID-19 Vaccine to include an additional presentation of the vaccine for booster vaccination doses only.  The new presentation is supplied in multiple dose vials with dark blue caps and labels with a purple border. The Moderna COVID-19 Vaccine is now authorized for individuals 18 years of … Continued

3/29/22 — The FDA issued warning letters jointly with the Federal Trade Commission to two companies for selling unapproved products with unproven COVID-19 claims. The companies that received warning letters are: Iodine Products Inc Applied Biological Laboratories Inc.

3/29/22 — The FDA issued warning letters jointly with the Federal Trade Commission to seven companies for selling CBD products using research studies to claim or imply misleadingly that their CBD products will cure, mitigate, treat or prevent COVID-19. Consumers concerned about COVID-19 should consult with their health care provider. The companies that received warning … Continued

3/29/22 — The FDA authorized and CDC recommended an additional COVID-19 booster for adults age 50 + and people age 12+ who are immunocompromised at least four months after receiving their first booster. Read the FDA authorization and the CDC recommendation.

3/29/22 — At the request of Pacific PPE Corporation, NIOSH has rescinded all respirator approvals issued to that company. Respirators bearing the following approval numbers may no longer be manufactured, assembled, sold, or distributed: • TC-84A-9278 • TC-84A-9299 • TC-84A-9313 Read the NIOSH notice of the voluntary rescission.

3/25/22 — The FDA has rescinded EUA for sotrovimab to treat COVID-19 in HHS Regions 1 and 2 because the authorized dose is unlikely to be effective against the Omicron BA.2 sub-variant. CDC Nowcast data estimates that, as of March 19, 2022, the BA.2 sub-variant accounts for more than 50 percent of COVID-19 cases in these regions. HHS Regions … Continued

3/25/22 — Plastikon Healthcare, LLC is voluntarily recalling three (3) lots of Milk of Magnesia 2400 mg/30 mL Oral Suspension, one (1) lot of Acetaminophen 650mg/ 20.3mL, and six (6) lots of Magnesium Hydroxide 1200mg/Aluminum Hydroxide 1200mg/Simethicone 120mg per 30 mL to the hospital, clinic and patient level.  The products are being recalled due to microbial … Continued