Public Policy Updates

5/17/22 — The FDA amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine to authorize the use of a single booster dose for individuals 5 to 11 years of age at least 5 months after completion of a primary series with the Pfizer vaccine. Read the FDA announcement.

5/13/22 — Fagron, Inc. is voluntarily recalling two lots of SyrSpend SF Cherry to the hospital, pharmacy, and distributor level out of an abundance of caution. The affected lots are potentially contaminated with Burkholderia gladioli. Fagron sells this product for the extemporaneous compounding of prescriptions for oral dosing. Exposure to contaminated product could lead to adverse events, which … Continued

5/16/22 — Woodside Acquisitions Inc. is recalling the Oral Rapid SARS-CoV-2 Antigen Rapid Test Kit and the Joysbio SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) because they were distributed to U.S. customers without authorization, clearance, or approval from the FDA. Read the FDA recall notice.

5/11/22 — The CDC is issuing a Health Alert Network (HAN) Health Update to provide updated information and recommendations about an epidemiologic investigation of pediatric cases of hepatitis of unknown etiology in the United States. As of May 5, 2022, CDC and state partners are investigating 109 children with hepatitis of unknown origin across 25 states … Continued

5/10/22 — SML Distribution LLC is recalling the Skippack Medical Lab SARS-CoV-2 Antigen Rapid Tests (Colloidal Gold). The FDA has identified this issue as a Class I recall, the most serious type of recall, because this test is not authorized, cleared, or approved by the FDA for distribution or use in the United States. The FDA … Continued

Mesa Biotech is recalling the Accula SARS-CoV-2 PCR Test because certain lots have an increased risk of giving false positive results due to contamination at the manufacturing facility. The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries, serious health consequences, … Continued

5/6/22 — The FDA cleared the Spectrum Medical Quantum Heater-Cooler and the compatible Qura Quantum PureFlow Heat Exchangers used to warm or cool a patient during cardiopulmonary bypass procedures. Instead of using water, the Quantum Heater-Cooler device regulates the temperature of a glycol-based heat transfer fluid (HTF), which then enters the compatible PureFlow heat exchangers to … Continued

5/5/22 — The FDA Administration has limited the authorized use of the Johnson & Johnson/Janssen COVID-19 Vaccine to individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, or who would otherwise not receive a COVID-19 vaccine. Updated evaluations led the FDA to determine that, … Continued

5/6/22 — The FDA issued a Letter to Healthcare Providers to share information about the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using the following hemodialysis machines manufactured by Fresenius Medical Care: the 2008T, 2008K2, and 2008K models. The 2008K2 and 2008K models are no … Continued