Class I · High risk Terminated
0.9% Sodium Chloride Injection
Reason Presence of Particulate Matter: Confirmed finding of human hair floating in IV solution.
FDA Drug Recalls
1,739 recalls · Class I, newest first
Class I · High risk Terminated
PHENYLephrine HCl
Reason Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair).
Class I · High risk Terminated
PHENYLephrine HCl
Reason Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair).
Class I · High risk Terminated
PHENYLephrine HCl
Reason Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair).
Class I · High risk Terminated
Fentanyl Citrate
Reason Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair).
Class I · High risk Terminated
Morphine Sulfate
Reason Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair).
Class I · High risk Terminated
Bupivacaine HCl 0.0625%
Reason Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair).
Class I · High risk Terminated
PHENYLephrine HCl
Reason Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair).
Class I · High risk Terminated
PHENYLephrine HCl
Reason Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair).
Class I · High risk Terminated
iNSANE Bee Pollen capsules
Reason Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared phenolphthalein and fluoxetine, making iNSANE an unapproved drug.
Class I · High risk Terminated
BtRiM Max capsules
Reason Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared phenolphthalein, making BtRiM Max an unapproved drug.
Class I · High risk Terminated
AMPD GOLD Bee Pollen capsules
Reason Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared sildenafil, making AMPD GOLD an unapproved drug.
Class I · High risk Terminated
iNDiGO capsules
Reason Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared phenolphthalein, making iNDiGO an unapproved drug.
Class I · High risk Terminated
EDGE Amplified Weight Release capsules
Reason Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared phenolphthalein and fluoxetine, making EDGE an unapproved drug.
Class I · High risk Terminated
0.9% Sodium Chloride Injection
Reason Presence of Particulate Matter; Hospira has identified the particulate as a human hair, sealed in the bag at the additive port area.
Class I · High risk Terminated
Avastin
Reason Non-Sterility: Product tested positive for bacterial contamination.
Class I · High risk Terminated
Avastin
Reason Non-Sterility: Product tested positive for bacterial contamination.
Class I · High risk Terminated
fentaNYL Citrate
Reason Subpotent Drug
Class I · High risk Terminated
fentaNYL Citrate
Reason Subpotent Drug
Class I · High risk Terminated
Practi-0.9% Sodium Chloride
Reason Non-sterility: Product is made in a non-sterile facility and is not intended for use in humans or animals.
Class I · High risk Terminated
Slim-K
Reason Marketed Without An Approved NDA/ANDA: Product was found to contain sibutramine, desmethylsibutramine and phenolphthalein based on FDA sampling and analysis.
Class I · High risk Terminated
Virginia Hospital Center
Reason Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class I · High risk Terminated
Spotsylvania Regional Med Ctr
Reason Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class I · High risk Terminated
Spotsylvania Regional Med Ctr
Reason Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Class I · High risk Terminated
Texas Health Presbyterian Dallas Neonatal Admit TPN 4 GM
Reason Non-Sterility: Out of specification results for the sterility test for microbial contamination.