Adverse Events and Recalls

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

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

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

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.

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

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

FDA's Drug Safety Priorities FY23 describes the center’s key safety programs and activities involved in promoting and protecting public health.

The agency’s safety committee stressed the risk of potential adverse reactions involved with taking Paxlovid (nirmatrelvir, ritonavir) in combination with certain immunosuppressants.

The company issued the recall because of a package mislabeling problem.

The agency is reviewing data on secondary malignancies related to T-cells for approved CAR T-cell medicines.

The European Medicines Agency safety committee says there is a potential risk of neurodevelopment disorders in children born to men treated with valproate.

The potential for superpotent drug initiated the voluntary recall.

The product is being voluntarily recalled because of powder leakage due to seal integrity issues.

Novartis has issued a nationwide voluntary recall of two lots of Sandimmune Oral Solution (cyclosporine oral solution, USP), 100 mg/mL because of crystallization issues.

VistaPharm is recalling Sucralfate Oral Suspension, 1g/10mL because of Bacillus cereus contamination.

Lower levels of an active ingredient may result in unexpected pregnancies.

Any patients who have received the identified lots or have any questions regarding the recall should contact their pharmacy or immediately contact a health provider in terms of medical advice.

Epinephrine is a critical medication used during life-threatening conditions that can affect any age and any person.

Pfizer has issued a voluntary nationwide recall of lots of Accupril due to N-nitroso-quinapril content.

Mylan Pharmaceuticals is issuing a voluntary recall of one batch of insulin glargine injection due to the potential for a missing label in the batch.

Teva has initiated a voluntary nationwide recall of one lot of IDArubicin Hydrochloride Injection USP 5mg/5 mL due to the presence of particulate matter.

Pfizer has issued a voluntary nationwide recall on lots of Accuretic tablets due to high levels of nitrosamine.

Olympia Pharmacy is voluntarily recalling eleven lots of seven compounded products due to out-of-specification results.

The company is voluntarily recalling one batch of Semglee prefilled pens because of a potential missing label.

The company is voluntarily recalling one lot of Senna Syrup 8.8mg/5mL, unit-dose cups because of microbial contamination.

Pfizer has expanded its voluntary recall to include all lots of varenicline (Chantix), but FDA allows continued distribution of the drug product to continue due to drug shortages.

Low- and middle-income countries are at the greatest risk of receiving substandard and falsified COVID-19 vaccines.

Japan has suspended the use of more than 1.63 million potentially contaminated doses of the Moderna vaccine.

KVK Tech is voluntarily recalling two lots of Atovaquone Oral Suspension, USP 750 mg/5mL because of customer complaints of unusual grittiness in the product.

The company is recalling one lot of Topotecan Injection 4 mg/4 mL (1 mg/mL) after a glass particle was found in a vial.