Safety & Recalls

Clinical data suggests an imbalance in vaso-occlusive crises and fatal events that require further assessment, and the company said it will provide updates in the future.

Veklury is indicated to treat adults and children who are hospitalized with COVID-19.

The FDA has identified a probable case of serious drug induced liver injury that occurred in a woman in the United States who had received Veozah. The agency is requiring additional liver blood testing after starting therapy.

The recalled batches have been found to have potassium chloride that does not dissolve, which can cause high potassium levels that can lead to hypertension, heart failure, or renal dysfunction.

Dr. Reddy’s is recalling five lots of Javygtor and one lot of generic sapropterin dihydrochloride because discoloration could lead to decreased potency. Sapropterin is used to treat an inherited metabolic disorder.

An additional seven lots of Treprostinil are affected on top of last month’s recall of one lot.

Bacillus cereus contamination in Atovaquone Oral Suspension, which treats AIDS-related pneumonia, was found during stability testing at a third-party lab.

The recommended maximum daily dose of Vancomycin is up to 2 grams a day. The overfilled vials could result in patients receiving up to 4 grams a day.

One lot of treprostinil injection is being recalled. Tresprostinil is a prostacyclin vasodilator used to treat patients with pulmonary arterial hypertension.

The FDA orders new warnings for CAR-T cell therapies due to reports of T-cell malignancies, including fatal cases, applying to BCMA- and CD19-directed genetically modified autologous T-cell immunotherapies.

The antihistamine drug carbinoxamine was found in one bottle Zenzedi, which is used to treat narcolepsy and ADHD.

Regulators are warning about the increased risk of very low blood calcium levels in patients with advanced chronic kidney disease.

Regulators will continue to evaluate a possible link by reviewing meta-analysis of clinical trials across all GLP-1 products and analyzing postmarketing data in the Sentinel System.

The presence of glass can lead to serious adverse events, including inflammation of a vein and blockage of blood vessels or life-threatening blood clots.

The FDA has seized thousands of units of counterfeit Ozempic 1 mg.

Cipla is recalling one lot of vigabatrin, which is used to treat seizures.

Shortages are growing because of disruption caused natural disasters and ingredient supply issues, as well as increased demand for certain drugs.

Regulators have found that medications containing levetiracetam and clobazam have led to drug reaction with eosinophilia and systemic symptoms (DRESS), a rare and severe drug allergy.

The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of May 25, 2024, for prademagene zamikeracel to treat patients with recessive dystrophic epidermolysis bullosa.

This is the second recall of Sandimmune related to the formulation of crystals in some bottles.

Contamination with Penicillium brevicompactum could lead to invasive fungal infections of the blood or pneumonia that can be life-threatening in immunocompromised patients.

Based on reports from post-marketing experience, Spravato’s warnings and precautions section now includes the risk of respiratory depression.

In total, 11 lots of three different products have been recalled because of silicone found in retained samples.

Betaxolol may cause a slowing in the heart rate in some patients; an opioid could increase the effect.

Contamination of Brexafemme with a non-antibacterial beta-lactam drug could lead to reactions such as swelling, rash, urticaria and anaphylaxis.

In patients who are immunocompromised, Bacillus cereus can result in life-threatening infections such as endocarditis and necrotizing soft tissue infections.

Crystal formation could lead under- or over-dosing of Sandimmune oral solution, which is used to prevent organ rejection in kidney, liver, and heart allogeneic transplants.

The mix-up in labels can cause either overdosing or underdosing in patients who unknowingly take the wrong dose. Digoxin is used to treat patients with heart failure and chronic atrial fibrillation.

The Association for Accessible Medicines (AAM) published a white paper on the impact that ongoing drug shortages have had on the generic and biosimilar industries, as well as possible solutions stakeholders can put into action.