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...
Teligent Pharma is recalling five lots of Lidocaine HCl topical solution 4%, 50mL after uncovered super potency. Use of super potent products can result in higher than intended doses of medication. Lidocaine hydrochloride works as a local anesthetic that can...
Bryant Ranch Prepack is recalling one lot of methocarbamol 500mg tablets, as the bottles labeled as 500mg tablets in fact contain 750mg tablets, and excessive dosing could result in central nervous system depression, which can cause nausea, sedation, fainting, falls,...
The FDA has expanded the emergency use authorizations (EUAs) for the Moderna and Johnson & Johnson COVID-19 vaccines to allow for the use of a single booster dose among certain populations. The Moderna vaccine may now be administered at least...
The White House announced plans to make COVID-19 boosters available for all adults starting the week of September 20th. Boosters could only be administered eight months after an individual’s second dose of the Pfizer or Moderna vaccine. In essence, during...
The FDA officially approved the Pfizer-BioNTech COVID-19 vaccine in late August. This is the first FDA-approved vaccine for the prevention of COVID-19 and potentially serious outcomes including hospitalization and death. Prior to this approval, COVID-19 vaccines had only received emergency...
The FDA amended the emergency use authorization (EUA) for both the Pfizer and Moderna COVID-19 vaccines to allow for an additional dose in certain immunocompromised individuals, specifically organ transplant recipients, or those who are diagnosed with conditions that are considered...
The FDA issued an emergency use authorization (EUA) for the investigational monoclonal antibody therapy sotrovimab for the treatment of mild-to-moderate COVID-19 in patients weighing at least 40 kilograms (about 88 pounds) with COVID-19 who are at high risk for progression...
Hospira voluntarily recalled lot EG6023 of 0.5% Bupivacaine Hydrochloride Injection and lot EG8933 of 1% Lidocaine HCl Injection, due to mislabeling whereby a portion of each lot was incorrectly labeled as the other product. Both drugs are indicated for the...
In April, the FDA and the CDC announced that six women experienced rare and severe blood clots after receiving the Johnson & Johnson COVID-19 vaccine. As of April 12, 2021, more than 6.8 million doses of this specific vaccine have...
