Quality Systems

Articles

The agency is recommending that the market authorization for Oxbryta (voxelotor) be suspended so that emerging data may be reviewed.

EMA Suspends Sickle Cell Disease Medicine

The company has issued a voluntary recall of one lot of Clonazepam Orally Disintegrating Tablets, USP (C-IV), because of incorrect strength published on product carton.

Endo Recalls Clonazepam Because of Mislabeling

PRAC is recommending that patients who use glucagon-like peptide-1 receptor agonists (GLP-1 RAs) consider the risk of delayed gastric emptying before undergoing surgery with general anesthesia or deep sedation.

EMA’s PRAC Offers Recommendations for Glucagon-like Peptide-1 Receptor Agonists and Glatiramer Acetate

Patrick Lavery is an Editor for the MJH Life Sciences brands 

. Previously at MJH, he filled the same role for 

This alert follows a similar one from the European Medicines Agency in October 2023 amid a rise in demand for the diabetes medication that, in turn, created a shortage.

WHO Warns About Falsified Ozempic Batches

PRAC is reviewing the risk of secondary malignancies in patients treated with CAR T-cell medicines. 

EMA Reviews Risks of CAR T-Cell Medicines and Painkillers

The units are being recalled because of incomplete crimp seals and one complaint of a leaking unit.

Hospira Recalls Buprenorphine Hydrochloride Injection Carpuject Units and Labetalol Hydrochloride Injection, USP Carpuject Units 

After a review, the agency concluded there was a possible risk of cancer to those exposed to 17-hydroxyprogesterone caproate in the womb.

EMA Suspends Hydroxyprogesterone Caproate Medicines in Europe

The agency’s risk assessment committee has concluded that available evidence has not been found that supports a causal association between glucagon-like peptide-1 receptor agonists and self-harming thoughts and actions.

EMA Says No Evidence for Link between Type 2 Diabetes Drugs and Suicidal Tendencies

The company is voluntarily recalling the product for potential super potent bottles due to overfilling.

Amneal Pharmaceuticals Recalls Vancomycin Hydrochloride for Oral Solution USP, 250 mg/5 mL

The company is recalling one lot of the product because of the potential presence of silicone particulates.

Adverse Events and Recalls