CHMP RECOMMENDS RECALL OF SELECTED BATCHES MFG AT BEN VENUE SUMMARY A joint GMP inspection of the Ben Venue site, where a number of sterile medicines are manufactured, by the UK and French medicines regulatory agencies together with the US FDA on 7-11 November 2011 highlighted several shortcomings in the quality management system, particularly in relation to the aseptic … [Read more...]
INSIGHT PHARMACEUTICALS ISSUE VOLUNTARY NATIONWIDE RECALL DUE TO BACTERIAL CONTAMINATION
RECALL TO CONSUMER LEVEL BECAUSE OF POSSIBLE BURKHOLDERIA CEPACIA COMMENT Insight Pharmaceuticals recalled 34,092 bottles of Nostrilla Nasal Decongestant nasal spray because it may contain the bacteria Burkholderia cepacia. This bacterium, known as a "specified" microorganism, has historically been a periodic … [Read more...]
RECALL OF PDI NON-STERILE ALCOHOL WIPES RAISES ADDITIONAL QUESTIONS SAYS MSNBC.COM
FRIEDMAN QUOTED AS SAYING THAT NON-STERILE GAUZE PADS SHOULD NOT BE USED WITH INJECTABLES COMMENT  JoNel Aleccia, Health Writer for MSNBC.com, questions the use of non-sterile wipes based upon a massive recall of potentially contaminated alcohol prep products by a second manufacturer. “Is there any place for a … [Read more...]
PDI, ORANGEBURG, NY IS RECALLING 285 MILLION NON-STERILE ALCOHOL PADS AS PER FDA ENFORCEMENT REPORT (10/5/11)
NON-STERILE WIPES FOUND TO BE CONTAMINATED BY FDA SAMPLING AND ANALYSES COMMENT FDA sampling and analyses of non-sterile alcohol prep pads were found to be contaminated with Bacillus cereus. Based on USP<61> and <62> wherein “specified” in-house microorganisms are considered objectionable, over 285 million packets are being recalled. Non-Sterile Alcohol Prep … [Read more...]
SECOND WIPE-MAKER ISSUES RECALL AFTER BACTERIA DETECTED
NON-STERILE WIPES RECALLED ON SEPTEMBER 16, 2011 FOLLOWING DISCOVERY OF LOW LEVELS OF BACILLUS CEREUS COMMENT Bacillus cereus was recently identified within non-sterile alcohol prep wipes manufactured by Professional Disposables International Inc (PDI), Orangeburg, NY. The recall of five lots are similar to the recalls of sterile and non-sterile wipes from H & P Industries … [Read more...]
