Class I · High risk
Dextrose Injection
Presence of Particulate Matter: Confirmed customer compliants of finding an insect floating in the primary container of each product.
FDA Drug Recalls
33 recalls · Class I, newest first
Class I · High risk
0.9% Sodium Chloride Injection
Presence of Particulate Matter: Confirmed customer compliants of finding an insect floating in the primary container of each product.
Class I · High risk
ADRUCIL (fluorouracil injection, USP)
Presence of Particulate Matter: silcone rubber and fluorouracil crystals found floating in solution
Class I · High risk
0.9% Sodium Chloride Injection USP
Presence of Particulate Matter: Customer complaint for an insect found free floating inside a single bag for each lot recalled.
Class I · High risk
0.9% Sodium Chloride Injection USP MINI-BAG Plus Container
Presence of Particulate Matter: Customer complaint for an insect found free floating inside a single bag for each lot recalled.
Class I · High risk
Adrucil (fluorouracil injection, USP)
Presence of Particulate Matter: Black particulate matter was identified as aggregate of silicone rubber pieces from a filler diaphragm and fluorouracil crystals.
Class I · High risk
Cytarabine Injection 100 mg/5 mL
Presence of Particulate Matter
Class I · High risk
Bupivacaine Hydrochloride Inj.
Presence of Particulate Matter: Presence of free-floating and embedded iron oxide particles.
Class I · High risk
EPINEPHrine HCl 4 mg added to 250 mL 0.9% Sodium Chloride Injection USP
Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP which were subsequently recalled by the manufacturer due to the presence of particulate matter.
Class I · High risk
HEPARIN Sodium Injection USP 25
Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP which were subsequently recalled by the manufacturer due to the presence of particulate matter.
Class I · High risk
EPINEPHrine HCl 16 mg added to 250 mL 0.9% Sodium Chloride Injection USP
Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP which were subsequently recalled by the manufacturer due to the presence of particulate matter.
Class I · High risk
HEPARIN Sodium Injection USP
Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP which were subsequently recalled by the manufacturer due to the presence of particulate matter.
Class I · High risk
EPINEPHrine HCl 1 mg added to 250 mL 0.9% Sodium Chloride Injection USP
Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP which were subsequently recalled by the manufacturer due to the presence of particulate matter.
Class I · High risk
oxyTOCIN 15 Units added to 250 mL 5% Dextrose Injection USP
Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP which were subsequently recalled by the manufacturer due to the presence of particulate matter.
Class I · High risk
Lactated Ringers Injection
Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)
Class I · High risk
10% Dextrose Injection
Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)
Class I · High risk
5% Dextrose Injection
Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)
Class I · High risk
0.9% Sodium Chloride Injection
Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)
Class I · High risk
Gemcitabine for Injection
Presence of Particulate Matter
Class I · High risk
Gemcitabine for Injection
Presence of Particulate Matter
Class I · High risk
Gemcitabine for Injection
Presence of Particulate Matter
Class I · High risk
CARBOplatin Injection 450 mg/45 mL
Presence of Particulate Matter
Class I · High risk
Methotrexate Injection
Presence of Particulate Matter
Class I · High risk
0.9% Sodium Chloride Injection
Presence of Particulate Matter: Confirmed finding of human hair floating in IV solution.
Class I · High risk
PHENYLephrine HCl
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).