Class I · High risk
Nano PNC Water
Marketed without an Approved NDA/ANDA and non-sterility: NANO PNC Water by nebulizer was sampled and found to contain variovorax paradoxus.
FDA Drug Recalls
5 recalls · Class I, newest first
Class I · High risk
Lidocaine HCL/ Sodium Bicarb
Non-Sterility: failed sterility test result.
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.