Out of an abundance of caution, FDA is taking the additional step of recommending that health care professionals and consumers not use any product that was produced by NECC at this time. [UPDATED 10/06/2012] On October 4, 2012, the CDC and FDA recommended that all health care professionals cease use and remove from their pharmaceutical inventory any product produced by the New … [Read more...]
FRANCK’S PHARMACY RECALLS ALL STERILE HUMAN AND VETERINARY PRESCRIPTIONS FROM NOV 21, 2011 TO MAY 21, 2012
ENVIRONMENTAL SAMPLING OF CLEAN ROOM REVEALED PRESENCE OF MICROORGANISMS AND FUNGAL GROWTH BY FDA. WHAT HAPPENED TO USP <797>? Franck's Pharmacy, Ocala, Florida initiated a recall of all sterile human and veterinary prescriptions from November 21, 2011 through May 21, 2012. This recall follows an earlier recall (May 2, 2011 Notice of Recall, … [Read more...]
HOSPIRA – WHEN IS A DRUG RECALL AN ALERT
 FDA RECOMMENDS ALERT TO AVOID DRUG SHORTAGES In a previous Blog (May 24, 2012) the issue of Warning Letters and how the FDA now on a routine basis is asking their Clients to advise them if the Warning Letter and its consequences will result in shortages was discussed. In this Blog, the FDA is using “Risk Management†… [Read more...]
Burkholderia cepacia: This Decision Is Overdue
FDA Believes Now is the Time to Remove the Bug from Pharmaceutical Manufacturing The FDA recently published an article wherein they discuss the rationale for removing B. cepacia from the pharmaceutical arena. They cite a number of reasons why they believe that this bacterium and its variants should no longer be permitted. These discussions are … [Read more...]
H&P’s ANATOMY OF A CONSENT DECREE (01/24/12)
H&P INDUSTRIES FULFILLS ITS INITIAL OBLIGATIONS AND RECEIVES RETURNED BOND H&P Industries has a recent history of receiving significant Form FDA 483s from the FDA. The consequence of these various recalls and 483s ultimately led to a seizure of raw materials, in-process product and final product by U.S. Marshalls. Subsequent to that H&P Industries entered into a … [Read more...]
