Class I · High risk
Ascorbic Acid Inj. Solution
Presence of Particulate Matter: Presence of glass particulates.
FDA Drug Recalls
151 recalls · Class I, newest first
Class I · High risk
Veklury (remdesivir)
Presence of Particulate Matter: Presence of glass particle.
Class I · High risk
2% Lidocaine HCl Injection
Presence of Particulate Matter: identified as glass.
Class I · High risk
1% Lidocaine HCl Injection
Presence of Particulate Matter: identified as glass.
Class I · High risk
4.2% Sodium Bicarbonate Injection
Presence of Particulate Matter: identified as glass.
Class I · High risk
Betaxolol Tablets
Presence of Foreign Tablets/Capsules: There is a potential presence of oxycodone HCl tablets, USP 5 mg in bottles.
Class I · High risk
Vancomycin Hydrochloride for Injection
Presence of Particulate Matter: Glass particulate matter detected in injectable.
Class I · High risk
Octreotide Acetate Injection 500 mcg/mL
Presence of Particulate Matter: Product complaint for the presence of glass particles in a syringe.
Class I · High risk
PROPOFOL Injectable Emulsion
Presence of particulate matter
Class I · High risk
Propofol Injectable Emulsion
Presence of particulate matter: particulate identified as a beetle.
Class I · High risk
IDArubicin Hydrochloride Injection USP 5gm/5mL
Presence of Particulate Matter: Product was found to contain silica and iron oxide
Class I · High risk
Sodium Acetate Injection
Presence of particulate matter: particulates composed of carbon and oxygen with varying amounts of iron and trace amounts of sodium, silicon, chromium, aluminum and cellulose.
Class I · High risk
Polymyxin B for Injection USP
Presence of Particulate Matter; product complaint of hair discovered in a vial within the lot
Class I · High risk
Veklury (remdesivir)
Presence of Particulate Matter: investigation into a customer complaint confirmed the presence of glass particulates.
Class I · High risk
Cubicin (daptomycin for injection)
Presence of Particulate Matter: Identified as Glass Particles
Class I · High risk
AMINOSYN II 15% An Amino Acid Injection
Presence of Particulate Matter: Particulate matter identified as fibers, hair, and proteinaceous material along with other particles, found in retain smples.
Class I · High risk
Topotecan Injection 4 mg/4mL
Presence of Particulate Matter: Complaint received of a glass particle observed inside the vial. The vial was returned to Teva for further analysis where two other particulates were found and identified as one (1) grey silicone particle and one (1) translucent, colorless cotton fiber.
Class I · High risk
Ketorolac Tromethamine Injection
Presence of Particulate Matter - found in reserve sample vials at the firm.
Class I · High risk
Daptomycin for Injection
Presence of Particulate Matter
Class I · High risk
LACTATED RINGER'S Injection
Presence of Particulate Matter: confirmed customer complaint for the presence of particulate matter identified as iron oxide.
Class I · High risk
Ketorolac Tromethamine Injection
Presence of Particulate Matter - found in reserve sample vials at the firm.
Class I · High risk
Ketorolac Trom
Presence of Particulate Matter: Medication relabeled at facility was recalled by the manufacturer due to small black particles noticed during routine visual inspection. of retain samples.
Class I · High risk
Ketorolac Tromethamine Injection
Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS)
Class I · High risk
0.9% Sodium Chloride Injection
Presence of Particulate Matter.
Class I · High risk
LACTATED RINGER'S Injection
Presence of Particulate Matter.