Class I · High risk
Lidocaine HCL/ Sodium Bicarb
Non-Sterility: failed sterility test result.
FDA Drug Recalls
150 recalls · Class I, newest first
Class I · High risk
Eye Wash
Non-Sterility: Direct evidence of contamination for 2 lots based on FDA samples.
Class I · High risk
Honeywell eyesaline Eyewash Sterile Isotonic Solution
Non Sterility; contaminated with Klebsiella pneumoniae
Class I · High risk
5% Dextrose Injection USP
Non-Sterility: fungal contamination due to leaking containers.
Class I · High risk
Human Chorionic Gonadotropin
Non-sterility: presence of mold confirmed by outside laboratory at the 14 day culture.
Class I · High risk
Prolotherapy with Phenol
Non-Sterility: Hartley Medical Center Pharmacy, Inc. is recalling Prolotherapy with Phenol due to non-sterility concerns.
Class I · High risk
Prolotherapy with Phenol
Non-Sterility: Hartley Medical Center Pharmacy, Inc. is recalling Prolotherapy with Phenol due to non-sterility concerns.
Class I · High risk
Lactated Ringer's Irrigation
Non-Sterility: Confirmed customer report of dark, fibrous particulates floating within the solution of the primary container, which were subsequently identified as mold
Class I · High risk
Avastin (Bevacizumab)
Non-Sterility: Product tested positive for bacterial contamination.
Class I · High risk
Avastin (Bevacizumab)
Non-Sterility: Product tested positive for bacterial contamination.
Class I · High risk
Practi-0.9% Sodium Chloride
Non-sterility: Product is made in a non-sterile facility and is not intended for use in humans or animals.
Class I · High risk
Virginia Hospital Center
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class I · High risk
Spotsylvania Regional Med Ctr
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class I · High risk
Spotsylvania Regional Med Ctr
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class I · High risk
Texas Health Presbyterian Dallas Neonatal Admit TPN 4 GM
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class I · High risk
Bayshore Medical Center
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class I · High risk
Bayshore Medical Center
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class I · High risk
Lankenau Hospital
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class I · High risk
Abington Memorial Hospital
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class I · High risk
Abington Memorial Hospital
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class I · High risk
Abington Memorial Hospital
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class I · High risk
Virtua West Jersey Voorhees
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class I · High risk
Robert Wood Johnson University
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class I · High risk
Robert Wood Johnson University
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class I · High risk
Hackensack University Med Ctr
Non-Sterility: Out of specification results for the sterility test for microbial contamination.