Category Archives: Recall

NEW ENGLAND COMPOUNDING CENTER (NECC) POTENTIALLY CONTAMINATED MEDICATION: FUNGAL MENINGITIS OUTBREAK

Posted on October 7, 2012 by

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 … Continue reading →

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FDA Safety Communication: Advanced Sterilization Products (ASP) Sterrad Cyclesure 24 Biological Indicators — Revised Expiration Dates

Posted on July 10, 2012 by

Date Issued:  July 3, 2012 Medical and Surgical Specialties: General Surgery, Surgical Technology, and any specialty that uses devices that must be sterilized at low temperatures Device: The Sterrad Cyclesure 24 Biological Indicator, manufactured by Advanced Sterilization Products (ASP), is a product … Continue reading →

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FRANCK’S PHARMACY RECALLS ALL STERILE HUMAN AND VETERINARY PRESCRIPTIONS FROM NOV 21, 2011 TO MAY 21, 2012

Posted on June 6, 2012 by

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, … Continue reading →

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HOSPIRA – WHEN IS A DRUG RECALL AN ALERT

Posted on May 30, 2012 by

 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 … Continue reading →

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Burkholderia cepacia: This Decision Is Overdue

Posted on May 1, 2012 by

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 … Continue reading →

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BEDFORD LABORATORIES ANNOUNCES VOLUNTARY MARKET RECALL (02/16/12)

Posted on February 24, 2012 by

RECALL CONDUCTED DUE TO A POST-RELEASE MANUFACTURING INVESTIGATION Bedford Laboratories, a division of Boehringer-Ingelheim announced on February 12, 2012 a recall for three lots of Cytarabine for Injection, USP. This “voluntary” market recall, announced with the knowledge of the FDA is … Continue reading →

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H&P’s ANATOMY OF A CONSENT DECREE (01/24/12)

Posted on February 15, 2012 by

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 … Continue reading →

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LEARN ABOUT THE FORM FDA 483s THAT LED TO THE NOVARTIS RECALL (1/08/12)

Posted on February 8, 2012 by

SPECIFIC OBSERVATIONS POINT TO THE EVENTUAL LINCOLN, NE RECALL Novartis Consumer Health, Inc. (NCH) received a Form FDA 483 containing 10 Observations representing 23 pages on January 20, 2012.  Several of the Observations were similar to those received in July 2011.  … Continue reading →

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VAGINA COSMETICS RECALLED FOR CONTAINING MICROORGANISMS AND BENZOCAINE

Posted on January 22, 2012 by

EFFECT OF MICROBIAL CONTAMINATION DIFFICULT TO ASSESS COMMENT USA Far Ocean Group issued a voluntary recall following FDA’s laboratory analyses of “Vagifresh Gel” and “Vagifresh Ball”.  The former contained benzocaine, while the later contained bacteria from a number of species to … Continue reading →

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BEN VENUE DETERMINES SIGNIFICANT REMEDIATION REQUIRED AT ITS BEDFORD, OHIO FACILITIES

Posted on January 3, 2012 by

“NORTH” FACILITY MAY NOT BE AVAILABLE FOR MFG OF STERILE INJECTABLES BEFORE 4th QUARTER 2012 COMMENT Ben Venue Laboratories issued an early “Christmas gift” press release on Friday, December 23 wherein they announced the decision to extend the voluntary suspension … Continue reading →

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