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The world's top drug maker recalled 191,000 bottles of its anti-cholesterol drug Lipitor due to reports of a moldy odor emanating from bottles supplied by a third-party – the same problem that ...
Patients and doctors with questions about the recall, should call Astellas at 800-727-7003, Monday through Friday, 9 a.m. to 5:30 p.m., Eastern time.
Pfizer Inc said on Monday it was recalling some lots of blood pressure drug Accuretic and two authorized cheaper versions of the drug due to the presence of a potential cancer-causing impurity ...
On 9 November 2012, Ranbaxy halted production and recalled 41 lots of atorvastatin due to glass particles being found in some bottles. [ 21 ] [ 22 ] Also in 2012, an apparent dosage mistake was reported in which 20 mg tablets were found in a bottle of atorvastatin labeled as containing 10 mg tablets; this led in 2014 to the voluntary recall in ...
A drug recall removes a prescription or over-the-counter drug from the market. Drug recalls in the United States are made by the FDA or the creators of the drug when certain criteria are met. When a drug recall is made, the drug is removed from the market and potential legal action can be taken depending on the severity of the drug recall. [1]
FDA's role under the guidelines is to monitor company recalls and assess the adequacy of a firm's action. After a recall is completed, FDA makes sure that the product is destroyed or suitably reconditioned and investigates why the product was defective. Generally, FDA accepts reports and other necessary recall information submitted by e-mail.
Pfizer (PFE) has announced the fourth recall of its blockbuster cholesterol drug Lipitor. The largest pharmaceutical in the world said that it intends to recall approximately 19,000 bottles of ...
The settlement amount includes both the civil (False Claims Act) settlement and criminal fine. Glaxo's $3 billion settlement included the largest civil False Claims Act settlement on record, [1] and Pfizer’s $2.3 billion ($3.5 billion in 2022) settlement including a record-breaking $1.3 billion criminal fine. [2]