Central Admixture Pharmacy Services Abington Memorial Hospital (PA) TPN Neonatal Starter> recall — FDA D-463-2015
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Browse U.S. drug recall enforcement reports from the FDA in a structured, searchable format. Review the recalled product, reason, firm, status, dates, distribution information and FDA classification when available.
10,690 detailed records are currently available in this category.
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Non-sterility: Product is made in a non-sterile facility and is not intended for use in humans or animals.
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.
Failed Stability Specifications: Product is subpotent and has out of specification known and unknown impurities.
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; increased complaints received for leaks
Failed Impurities/Degradation Specification; out of specification results for carbon dioxide
Lack of Assurance of Sterility. Complaints were receive of missing closures and/or leaks which may compromise product sterility.
Lack of Assurance of Sterility; due to leaking vials
Lack of Assurance of Sterility; due to leaking vials
Failed Impurities/Degradation Specifications; 12 month stability testing.
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