November 29th 2023
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.
November 27th 2023
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.
November 20th 2023
Contamination with Penicillium brevicompactum could lead to invasive fungal infections of the blood or pneumonia that can be life-threatening in immunocompromised patients.
October 27th 2023
Based on reports from post-marketing experience, Spravato’s warnings and precautions section now includes the risk of respiratory depression.
Recall Impacts Exela and Civica Brands
In total, 11 lots of three different products have been recalled because of silicone found in retained samples.
Oxycodone on Packaging Line Leads to Recall of Betaxolol
Betaxolol may cause a slowing in the heart rate in some patients; an opioid could increase the effect.
Cross-Contamination Leads to Recall of Two Lots of Brexafemme
Contamination of Brexafemme with a non-antibacterial beta-lactam drug could lead to reactions such as swelling, rash, urticaria and anaphylaxis.
Potential Contamination Leads to Recall of VistaPharm’s Sucralfate
In patients who are immunocompromised, Bacillus cereus can result in life-threatening infections such as endocarditis and necrotizing soft tissue infections.
Crystal Formation in Bottles Leads to Recall of Sandimmune
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.
Label Mix Up Leads to Recall of Digoxin
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.
AAM: Market Factors Contribute to Drug Shortage Crisis
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.
Stability and Purity Issues Lead to Recall of Tydemy
One of the two recalled lots of the birth control tested high for a known impurity.
Pfizer Tornado Plant Damage Not Affecting Penicillin Supply
The supply of fentanyl, epinephrine injection, and heparin, however, have been impacted by the July 19 tornado at Pfizer's North Carolina facility.
Leaking Inhaler Valve Leads to Recall of Six Batches of Cipla’s Albuterol
There is a risk the inhaler wouldn’t provide the right dose.
Pfizer Cautions About Shortages of Certain Bicillin Formulations
The supply interruption is the result of a combination of factors, including significant increases in demand, an increase in syphilis infection rates, as well as competitive shortages.
Labeling Mix up Leads to Recall of Dronabinol and Ziprasidone
Ziprasidone is used to treat patients with schizophrenia and bipolar disorder. Taking dronabinol instead may lead to worsening of mental illness symptoms.
Quality Issues Lead to Shortages of Common Cancer Drugs
More than 90% of cancer centers have experienced shortages of critical drugs. Erin R. Fox, Pharm.D., University of Utah Health, talks about why these shortages are happening and efforts that are being made to address them.
FDA Warns About Certain Compounded Semaglutide Products
The FDA has received adverse event reports after patients have used compounded semaglutide that contains salt formulations, which are different active ingredients than that used in the agency-approved drugs for diabetes and weight loss.
Brexpiprazole Approved as First Drug for Agitation Related to Dementia in Adults with Alzheimer’s Disease
The FDA approved Rexulti (brexpiprazole) for Alzheimer’s-related agitation based on the findings of two clinical trials.
FDA Requires New Warnings For Prescription Opioids in Another Step to Prevent Overdoses
One of the warnings regard the risk of opioid-induced hyperalgesia, a condition associated with taking opioids that causes an increase in pain or an increased sensitivity to pain.
AbbVie Withdraws Two Blood Cancer Indications From Imbruvica
Other indications for the blockbuster cancer mediation are not affected.
FDA Officially Withdraws Makena, the Only Preterm Birth Med
Issued jointly by the FDA Commissioner and Chief Scientist, the decision means Makena and its generics are no longer approved and cannot lawfully be distributed in interstate commerce. At the same time, the agency “recognizes that there is a supply of product that has already been distributed.”
Impurities Lead to Recall of 10 Lots of Dabigatran
The presence of a cancer-causing nitrosamine was found in the product, an oral anticoagulant to lower the risk of stroke and blood clots.
Bacterial Contamination Leads to Recall of Antifungal Drug
Atovaquone Oral Suspension, which treats AIDS-related pneumonia, is being called because of the potential of Bacillus cereus contamination that could lead to life-threatening infections.
CDC Warns About Drug-Resistant Stomach Infections
Shigella cause an estimated 450,000 infections in the United States each year and an estimated $93 million in direct medical costs.
Cracked Lids Leads to Recall of Six Lots of Brimonidine Tartrate Solution
Brimonidine tartrate ophthalmic solution is used to reduce elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
BMS Warns of Liver Damage from Sprycel
Patients who have had liver problems in the past may be at risk of liver damage from Sprycel, which is used to treat patients with chronic myeloid leukemia.
FDA Warns About Hospira’s Pediatric Indication on Potassium Phosphates
Hospira/Pfizer’s potassium phosphates product alone may produce daily aluminum exposures of up to twice of the FDA-recommended limit for children.
FDA Warns Companies Claiming to Treat Monkeypox
The products may be ineffective, unsafe and could prevent a person from seeking an appropriate diagnosis.
Subpotency Leads to Recall of 27 Lots of Tirosint-SOL
IBSA Pharma is recalling the hypothyroid medication because analyses showed lowered levels of levothyroxine in some lots.
Daiichi Sankyo Makes Available New Dosing Regimen for Turalio
Dosing has been lowered to reduce the risk of liver damage in patients taking Turalio, which is approved to treat patients with a rare tumor that affects the joints.
Discolored Product Leads to Recall of Epinephrine Ingredient
Epinephrine (L-adrenaline) is a bulk active pharmaceutical ingredient used to manufacture or compound prescription products.
Glass Particles in Vial Lead to Vancomycin Recall
Hospira is calling one lot of vancomycin hydrochloride, an antibiotic to treat patients with serious infections caused by methicillin-resistant staphylococci.
Best Read Product Recall Stories in 2022
Among the most-read product recall stories are those of amoxicillin, metformin, sodium bicarbonate Omnipod 5, and clopidogrel and atenolol.
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