Class II · Moderate risk
Octreotide Acetate for Injectable Suspension
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Sterility & contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections.
6,317 FDA drug recalls with this cause, newest first.
This is the single biggest cause in the register by a wide margin. It covers products that had to be sterile - injectables, eye drops, certain ointments - but could not be verified sterile, or were found contaminated during testing. Most of these recalls come from compounding pharmacies and outsourcing facilities after an FDA inspection finds gaps in how sterile products were made. Sterility failures are treated seriously because the products involved have the least room for error, going straight into the bloodstream or the eye.
Class II · Moderate risk
Similasan
Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.
Class II · Moderate risk
iVIZIA
Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.
Class II · Moderate risk
BD PurPrep
Lack of assurance of Sterility: potential product contamination
Class II · Moderate risk
BD PurPrep
Lack of assurance of Sterility: potential product contamination
Class II · Moderate risk
GenTeal Tears
Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
Class II · Moderate risk
Systane
Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
Class II · Moderate risk
Optase Dry Eye Intense Drops
Lack of Assurance of Sterility
Class II · Moderate risk
Freshkote Lubricant Eyedrops
Lack of Assurance of Sterility
Class II · Moderate risk
Delflex
Lack of Assurance of Sterility: Potential leaks from perforations in bags.
Class II · Moderate risk
Delflex
Lack of Assurance of Sterility: Potential leaks from perforations in bags.
Class II · Moderate risk
Lidocaine HCl Injection
Lack of Assurance of Sterility
Class II · Moderate risk
0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Bupivacaine Hydrochloride 0.75% in 8.25% Dextrose Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Lidocaine HCl injection
Lack of Assurance of Sterility
Class II · Moderate risk
Lactated Ringer's Irrigation
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Class II · Moderate risk
0.9 % Sodium Chloride Irrigation
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Class II · Moderate risk
Dextrose Injection USP
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Class II · Moderate risk
Sterile Water for Injection USP
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Class II · Moderate risk
EPINEPHRINE Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Artificial Tears Lubricant Eye Drops
Lack of Assurance of Sterility
Class II · Moderate risk
Vancomycin HCL
Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Class II · Moderate risk
Vancomycin HCI
Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Class II · Moderate risk
Vancomycin HCI
Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Class II · Moderate risk
norepinephrine Bitartrate
Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
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