Alvogen, Inc. is voluntarily recalling one lot of Fentanyl Transdermal System 25 mcg/h transdermal patches due to the potential that patches could be multi-stacked, adhered one on top of the other, in a single product pouch. There is a possibility...
Endo, Inc. announced a voluntary recall of Clonazepam Orally Disintegrating Tablets, USP (C-IV) due to potential product carton strength mislabeling. Various Clonazepam products with the lot number 550176501 may contain the incorrect strength and National Drug Code (NDC) code, thought...
The FDA has determined that the shortage of tirzepatide injections (a GLP-1 antagonist) has been resolved, meaning compounders can no longer create their own formulations of this drug. The FDA is reminding compounders of legal restrictions on making copies of...
The FDA granted marketing authorization for the Healgen Rapid Check COVID-19/Flu A&B Antigen Test. The test, authorized for use without a prescription, is for use by individuals experiencing respiratory symptoms and uses a nasal swab sample to deliver at-home results...
The FDA declined to approve a new drug application for MDMA as a treatment for PTSD. The FDA cited insufficient data, requesting additional clinical trial data to assess safe and effective use. The initial application presented positive data from two...
One lot of Healthy Living Migraine Relief (acetaminophen, aspirin and caffeine) tablets (Lot No AC2523005A) was recalled due to a missing product label. This product lacks required labeling information, drug facts, and patient usage information. There is significant risk of...
A lot of clonazepam orally disintegrating tablets (Lot No 550147301) has been recalled due to mislabeling with incorrect strength on the carton. Clonazepam can be used to treat seizures, as well as panic and anxiety disorders. The product labeling shows...
One lot of acetaminophen injections 1000mg/100mL, (10mg/mL) was recalled (Lot No24070381), due to the possible presence of a bag labeled dexmedetomidine inside the acetaminophen overwrap. If a provider administers dexmedetomidine instead of acetaminophen, there are multiple potential adverse outcomes that...
The FDA issued an alert to providers, compounders, and patients of dosing errors associated with compounded injectable semaglutide products, due to reports of adverse events, some requiring hospitalization, that may be related to overdoses due to dosing errors associated with...
Hospira, Inc., a Pfizer company, is voluntarily recalling two lots of Buprenorphine Hydrochloride Injection Carpuject Units due to the potential for incomplete crimp seals; one customer complaint has been received for one leaking unit. In the event that impacted products...
The FDA received reports of allergic-type reactions potentially related to sulfite-containing compounded drugs. FDA is alerting health care professionals, compounders and patients about the risk of potentially serious allergic-type reactions to sulfite-containing compounded drugs. Health care professionals and patients may...
The DEA announced plans to reschedule marijuana from a Schedule I drug to a Schedule III drug. Rescheduling marijuana would not make it legal for recreational use, as Schedule III drugs are still controlled substances and subject to rules and...
Eugia US LLC – also known as AuroMedics Pharma LLC – initiated a voluntary recall of lot number 3MC23011 of Methocarbamol Injection, USP 1000 mg/10 mL (100mg/mL) (Single Dose Vial) - 10mL Vial to the consumer level due to a...
The FDA has received adverse event reports after patients used compounded semaglutide, including reports that in some cases, compounders may be using salt forms of semaglutide, including semaglutide sodium and semaglutide acetate. These salt forms are different active ingredients than...
The FDA approved the first test that uses DNA in assessing whether certain individuals may have an elevated risk of developing opioid use disorder (OUD). As part of a clinical evaluation, the AutoGenomics, Inc. AvertD test is intended to be...
