Central Admixture Pharmacy Services Holy Cross Hospital (MD) AA3%TPN Neonatal Day 1 Bag recall — FDA D-449-2015
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Complete FDA and NHTSA recall records dated in April 2015.
These records include useful source details for the selected month.
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Lack of Assurance of Sterility. A recent FDA inspection reported GMP violations potentially impacting product quality and sterility.
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Failed Impurities/Degradation Specifications: out of specification results for a related compound - a degradant of fexofenadine.
Presence of Particulate Matter: Confirmed customer complaints received for the presence of blue plastic, identified as fragments of the frangible from the vial adapter.
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Failed Impurities/Degradation Specifications: A stability lot was out of specification for a known impurity at the 8 month Controlled Room Temperature stability time-point.
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
San Juan Salsa Co. is recalling six varieties of salsa due to potential peanut contamination.
Christ Kitchen is recalling Blameless Blondies, a dry bakery mix, because milk, soy and wheat allergens are not declared in product labeling.
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.