The FDA is warning consumers not to purchase or use products marketed with variations of the names “Artri” or “Ortiga” due to potentially dangerous hidden active drug ingredients not listed on the product label. These products are marketed as treatments...
The FDA has limited the authorized use of the Johnson & Johnson/Janssen COVID-19 Vaccine to individuals for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, and to individuals who elect to receive the Johnson &...
Sandoz Inc. issued a recall of 13 lots of Orphenadrine Citrate 100 mg Extended Release (ER) tablets to the consumer level due to the presence of a nitrosamine impurity. Orphenadrine is used as an adjunct to rest, physical therapy, and...
The FDA authorized a second booster dose of either the Pfizer or Moderna COVID-19 vaccines for individuals aged 50 and older at least four months after their first booster dose, and for immunocompromised individuals at least four months after their...
The CDC announced proposed draft updates to the Clinical Practice Guideline for Prescribing Opioids. This draft notice is available to the public and can be commented on until April 11, 2022. The CDC’s opioid guidelines have shaped opioid prescribing policies...
The FDA issued an emergency use authorization (EUA) for bebtelovimab, a monoclonal antibody, for the treatment of mild-to-moderate COVID-19 that retains activity against the omicron variant in patients weighing at least 88 pounds who are at high risk of progression...
The FDA issued an emergency use authorization (EUA) for Evusheld (tixagevimab co-packaged with cilgavimab and administered together) for the pre-exposure prophylaxis of COVID-19. This product is only authorized for individuals not currently infected with COVID-19 who were recently exposed to...
The FDA issued an emergency use authorization (EUA) for Paxlovid (nirmatrelvir tablets and ritonavir tablets co-packaged for oral use) for the treatment of mild-to-moderate COVID-19 in patients who are high risk for progression to severe COVID-19, including hospitalization or death....
The FDA issued an emergency use authorization for molnupiravir for the treatment of mild-to-moderate COVID-19 who are at high risk of progression to severe COVID-19, including hospitalization and death, and for whom alternative COVID-19 treatments are not accessible or clinically...
The FDA is warning that dental problems have been reported with medicines containing buprenorphine that are dissolved in the mouth. Dental problems, including tooth decay, cavities, oral infections, and loss of teeth, can be serious and have been reported even...
Sagent Pharmaceuticals issued a recall for four lots of Levetiracetam Injection, USP due to a lack of sterility assurance. Levetiracetam is used for the treatment of certain types of seizures. Intravenous administration of a product intended to be sterile that...
The FDA issued emergency use authorizations for all currently available COVID-19 vaccines – Pfizer, Moderna, Johnson & Johnson – allowing all adults aged 18 and older to receive a booster dose. Individuals must complete their initial vaccine series prior to...
Gilead Sciences Inc issued a recall of two lots of Veklury (remdesivir) injections due to the presence of glass particulates. Remdesivir is indicated for the treatment of severe COVID-19 that requires hospitalization. The administration of an injectable product containing glass...
Teligent Pharma issued a recall for two lots of Lidocaine HCl topical solution USP 4% 50ml due to super potency. Lidocaine is used as a local anesthetic, but an increased lidocaine dose could lead to systemic toxicity depending on the...
The FDA updated the emergency use authorization (EUA) for the combined administration of bamlanivimab and etesevimab – two monoclonal antibodies – to include emergency use as a post-exposure prophylaxis (prevention) for COVID-19 patients aged 12 or older who are at...
