Class II · Moderate risk
METRONIDazole Injection
Lack of Assurance of Sterility: There is the potential for the solution to leak from the administrative port to the fill tube seal.
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Class II · Moderate risk
0.9% Sodium Chloride Irrigation
Lack of Assurance of Sterility: There is a potential for the solution to leak from the administration port of the primary container.
Class I · High risk
Lactated Ringer's and 5% Dextrose Injection
Non-Sterility: Confirmed customer complaint of product contaminated with mold.
Class II · Moderate risk
Furosemide Injection USP
Lack of Assurance of Sterility; possible loose crimp applied to fliptop vial
Class II · Moderate risk
0.9% Sodium Chloride Injection USP
Lack of Assurance of Sterility: There is the potential for solution to leak from the administrative port to the fill tube seal.
Class I · High risk
Mitosol (mitomycin for solution)
Non-Sterility: one or more components of the kit have been found to be contaminated with yeast.
Class I · High risk
Cyanocobalamin 1000 mcg/ml
Non-Sterility: Green Valley Drugs received positive sterility results from their testing lab on two lots of Methylprednisolone Preservative Free 40 mg/mL injectable suspension and one lot of Cyanocobalamin 1000 mcg/mL injection, 30 mL MDV.
Class I · High risk
Methylprednisolone Preservative Free 40 mg/ml Injectible Suspension
Non-Sterility: Green Valley Drugs received positive sterility results from their testing lab on two lots of Methylprednisolone Preservative Free 40 mg/mL injectable suspension and one lot of Cyanocobalamin 1000 mcg/mL injection, 30 mL MDV.
Class III · Low risk
TORISEL Kit
Lack of Assurance of Sterility; potential that a low level of endotoxins may be present in the diluent vials.
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.
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 I · High risk
Lactated Ringer's and 5% Dextrose Injection
Non-Sterility: One confirmed customer report that product contained spore-like particulates, consistent with mold.
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