2013

The Centers for Disease Control and Prevention are concerned about the threat posed by an over-reliance on antibiotics.  The worry is that continued exposure to these types of therapies is actually creating the perfect storm for bacteria that are becoming resistant to medication.  This can create superbugs that are far more dangerous than the typical… read more

A Mohali, India-based plant will no longer be allowed to ship drugs approved by the Food and Drug Administration into the United States until such time that the plant is brought into line with current good manufacturing practices.  The FDA put forth this import alert pertaining to a Ranbaxy plant after inspections from last year… read more

If you follow recalls, you will have noticed a recent surge in the last few months in the number of announcements related to compounding pharmacies.  That’s because the Food and Drug Administration appears to have taken a renewed interest in compounded medication on the heels of a fungal meningitis outbreak that reportedly killed 64 people…. read more

Two lots of Bevacizumab set to expire on November 3 and one lot of Lidocaine/phenylephrine set to expire on October 28 are being recalled because there’s a possibility that they are not sterile.  The concern arose in conjunction with an inability by Front Range Laboratories to meet certain quality standards during an inspection by the… read more

In order for a patient to safely take a medication, he or she must be properly informed as to what the medication does and what risks are inherently involved in the intake of a drug.  That’s why labels are so important.  They inform patients of the proper dosage instructions and illustrate the potential side effects… read more

When you’re prescribed medication, following the directions of your doctor and the label of the drug is essential to ensuring safety.  But those are far from the only precautions that might be taken.  A new report offers some tips from a Valencia-based pharmacy manager that persons can put into practice in order to ensure safety…. read more

Vancomycin PF (BSS) 1% and Bevacizumab 1.25 mg/0.05 mL PF are being recalled by Avelia Specialty Pharmacy over fears that the sterility of the items cannot be assured.  These compounded products had been sent to Front Range Laboratories for sterility testing, but recent inspections by the Food and Drug Administration have revealed that the practices… read more

Multiple preparations are being recalled by the San Diego, California-based University Compounding Pharmacy due to a potential shortfall in sterility.  The recall comes on the heels of the revelation that the third-party lab tasked with testing for sterility of these products may have engaged in practices that call into question the viability of that confirmation. … read more

Following a series of inspections that reportedly turned up potential safety issues, Dakota Laboratories will be unable to manufacture or distribute drugs until they can prove that the problems have been corrected.  This consent decree of permanent injunction was requested by the Food and Drug Administration after inspections from 2010 through 2012 turned up violations… read more

500 milligram versions of Cubicin (daptomycin for injection) are being recalled by the Lexington, Massachusetts-based Cubist Pharmaceuticals due to concerns about the possibility of particulate matter within the injections.  If a patient is exposed to some type of glass particulate, they could suffer from such things as an embolism, phlebitis, granulomas, and more.  A supplier… read more

Six types of medication are being recalled due to worries about the sterility of the items.  The Birmingham, Alabama-based Wellness Pharmacy announced the recall, which affects R.L. Glutathione 100mg/ml SUV PF, Methylcobalamin 1mg/ml, Dexpanthenol 250mg/ml, Sodium Phenylbutyrate 200mg/ml SDV PF, Ascorbic acid (cassava) 500mg/ml PF SUV, and Magnesium sulfate 50%.  A Food and Drug Administration… read more

The Food and Drug Administration is taking steps to ensure that studies designed to determine whether or not certain drugs would be safe for children are carried out in a safe and efficient manner.  Thanks to Congress’s recent reauthorization of the Pediatric Research Equity Act, the FDA is now able to extend the deadline by… read more