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.
FDA Drug Recalls
184 recalls · Class I, newest first
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.
Class I · High risk
Fluorouracil Injection
Presence of Particulate Matter; glass particulates
Class I · High risk
Mycophenolate Mofetil for Injection
Presence of Particulate Matter; glass fragment observed in one vial of reconstituted product
Class I · High risk
Lidocaine HCl Injection
Presence of Particulate Matter: One vial was found to contain a hair.
Class I · High risk
8.4% Sodium Bicarbonate Injection
Presence of Particulate Matter; glass particulates
Class I · High risk
Levoleucovorin Injection
Presence of Particulate Matter: particulate matter identified as copper salts
Class I · High risk
Vecuronium Bromide for Injection 20 mg* *1mg/mL when reconstituted to 20 mL Lyophilized
Presence of Particulate Matter: Foreign matter identified as glass detected in Vecuronium Bromide for Injection.
Class I · High risk
Vecuronium Bromide for Injection 10 mg*
Presence of Particulate Matter: Foreign matter identified as glass detected in Vecuronium Bromide for Injection.
Class I · High risk
Ceftriaxone for Injection USP
Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.
Class I · High risk
Ceftriaxone for Injection USP
Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.
Class I · High risk
Ceftriaxone for Injection USP
Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.
Class I · High risk
Ceftriaxone for Injection USP
Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.
Class I · High risk
Piperacillin and Tazobactam for Injection USP 3.375 grams per vial
Presence of Particulate Matter: identified as glass and silicone material
Class I · High risk
Naloxone Hydrochloride Injection
Presence of Particulate Matter; Potential for particulate matter on the syringe plunger.
Class I · High risk
Piperacillin and Tazobactam for Injection
Presence of Particulate Matter: confirmed customer report for presence of visible particulate matter, confirmed as glass
Class I · High risk
Ampicillin and Sulbactam for Injection
Presence of Particulate Matter: confirmed customer report of the presence of visible particulate matter believed to be red rubber particles from the manufacturing process of the active ingredients.
Class I · High risk
Ampicillin and Sulbactam for Injection 1.5 g vial
Presence of Particulate Matter: A confirmed customer report was received for the presence of visible particulate matter, confirmed as glass, within a single vial.
Class I · High risk
Pantoprazole Sodium for Injection
Presence of Particulate Matter: One vial from a lot of Pantoprazole Sodium for Injection (40 mg) contained a piece of glass
Class I · High risk
Nexterone (amiodarone HCl)
Presence of Particulate Matter:Particulate identified as polyethylene, the primary constituent of the film and ports used to manufacture the bag in which product is packaged
Class I · High risk
Vancomycin Hydrochloride for Injection
Presence of Particulate Matter: glass particulate found in vial
Class I · High risk
BRILINTA (ticagrelor)
Presence of Foriegn Tablets/Capsules: customer complaint that an 8-count professional sample bottle labeled as BRILINTA 90 mg tablets contained 5 ZURAMPIC 200 mg tablets, in addition to the expected 8 BRILINTA tablets.
Class I · High risk
Infant 25% DEXTROSE Injection
Presence of Particulate Matter: human hair found within an internal sample syringe.