Class II · Moderate risk
Nalbuphine HCl Injection
Lack of Assurance of Sterility: Complains of a loose crimp applied to the fliptop vial; and a missing stopper and flip cap were received and therefore sterility cannot be assured.
FDA Drug Recalls
237 recalls · Class II, newest first
Class II · Moderate risk
VIVITROL (naltrexone for extended-release injectable suspension)
Lack of Assurance of Sterility: Product did not meet the criteria for container closure integrity testing during routine 24 month stability testing.
Class II · Moderate risk
All Sterile Products manufactured by Ameridose LLC
Lack of assurance of sterility
Class II · Moderate risk
HEXTEND 6% Hetastarch in Lactated Electrolyte Injection
Lack of Assurance of Sterility: There is the potential for the solution to leak from the seal of the fill tube to the bag.
Class II · Moderate risk
All Sterile Products manufactured by NECC
Lack of Assurance of Sterility
Class II · Moderate risk
Cyanocobalamin Injection
Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles.
Class II · Moderate risk
Ondansetron Injection
Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles.
Class II · Moderate risk
Midazolam Hydrochloride Injection
Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles.
Class II · Moderate risk
Triamcinolone 10 mg/mL P
Lack of Assurance of Sterility
Class II · Moderate risk
Saline 10% and 3%
Lack of Assurance of Sterility
Class II · Moderate risk
Omnipaque 240mg/mL PF
Lack of Assurance of Sterility
Class II · Moderate risk
Lidocaine 1% PF
Lack of Assurance of Sterility
Class II · Moderate risk
Lidocaine/Dextrose 5%/7.5% PF
Lack of Assurance of Sterility
Class II · Moderate risk
Isovue 200 mg/mL PF and 300 mg/mL PF
Lack of Assurance of Sterility
Class II · Moderate risk
Hyaluronidase 150 u/ml PF
Lack of Assurance of Sterility
Class II · Moderate risk
Glycerin 100% PF
Lack of Assurance of Sterility
Class II · Moderate risk
Dexamethasone Sodium Phosphate 4 mg/mL vials PF
Lack of Assurance of Sterility
Class II · Moderate risk
Clonidine 100 mcg/mL PF
Lack of Assurance of Sterility
Class II · Moderate risk
Bupivacaine 0.25% PF
Lack of Assurance of Sterility
Class II · Moderate risk
Betamethasone Sodium Phosphate 6 mg/mL P Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Betamethasone Repository 6 mg/mL PF Injection and Betamethasone…
Lack of Assurance of Sterility
Class II · Moderate risk
Cymevene 500 mg Powder for Infusion
Lack of Assurance of Sterility; container closure issues with the bulk batch.
Class II · Moderate risk
Diazepam Injection
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
Class II · Moderate risk
Preservative-Free MORPHINE Sulfate Injection
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial
Class II · Moderate risk
I-C Drops
Lack of Assurance of Sterility: The product is being recalled because the product label does not state sterile in accordance with 21 CFR Part 200.50(a)(1), Ophthalmic Preparations and Dispensers, and it is not in compliance with 21 CFR Part 349, Ophthalmic Drug Products for Over-The-Counter Use.