Sagent Pharmaceuticals Initiates a Nationwide Voluntary Recall of Atracurium Besylate Injection, USP, 50mg/5mL and 100mg/10mL due to FDA Observations Pertaining toAseptic and GMP Practices at the Manufacturer’s Site Potentially Impacting Product Sterility Schaumburg, … [Read more...]
TESTING LABORATORY RECEIVES STERILITY OBSERVATIONS
FDA FINDS LABORATORY CONDUCTING STERILITY AND ENDOTOXIN TESTING FOR COMPOUNDING CENTERS HAS SIGNIFICANT ISSUES WITH STERILITY ASSURANCE The FDA recently audited Front Range Laboratories, Loveland, CO from August 5 through August 30, 2013. Their five investigators issued a five Observation, twelve page document. Enclosed is Observation 1 which … [Read more...]
WOCKHARDT LIMITED, AURANGABAD, INDIA RECEIVES WARNING LETTER (7/18/13)
FIRM IS CITED FOR WITHOLDING TRUTHFUL INFORMATION AND DELAYING AND LIMITING THE INSPECTION Wockhardt Ltd was recently audited by the FDA during the timeframe of March 18 – 22, 2013 at their Biotech Park, Aurangabad, India. During this audit the FDA documented that Wockhardt Ltd was found to have withheld truthful information, and delayed and limited the inspection. The delay … [Read more...]
FDA APPROVES RAXIBACUMAB TO TREAT INHALATION ANTHRAX (12/14/12)
FIRST MONOCLONAL APPROVED UNDER FDA'S ANIMAL EFFICACY RULE The U.S. Food and Drug Administration today approved raxibacumab injection to treat inhalational anthrax, a form of the infectious disease caused by breathing in the spores of the bacterium Bacillus anthracis. Raxibacumab also is approved to prevent inhalational anthrax when alternative therapies are not available or … [Read more...]
PRELIMINARY REPORT OF NEW ENGLAND COMPOUNDING CENTER ISSUED BY MASSACHUSETTS DEPARTMENT OF PUBLIC HEALTH (DPH) (10/23/12)
NOTES FAILURE TO COMPLY WITH USP <797> AND STATE LAWS AND REGULATIONS BACKGROUND “Pharmacy Compounding†involves modifying commercially available products to meet the requirements of an individual patient based upon a prescription from a licensed provider. Within the State of Massachusetts, a total of 25 pharmacies meet … [Read more...]
