Class II · Moderate risk
Gentamicin buffered 36.4 mg/ml
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
FDA Drug Recalls
6,161 recalls · Class II, newest first
Class II · Moderate risk
Estradiol Valerate 30 mg/ml
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class II · Moderate risk
Estradiol Valerate 20 mg/ml
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class II · Moderate risk
Estradiol Cypionate 5 mg/ml
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Class II · Moderate risk
Diazepam 5 mg/ml
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Class II · Moderate risk
Cyclosporine 2% ophthalmic
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Class II · Moderate risk
Cyclosporine 1% ophthalmic drops
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Class II · Moderate risk
Cataract drops
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Class II · Moderate risk
Acetylcysteine 2 % Solution
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Class II · Moderate risk
Acetylcysteine 20 % solution
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Class II · Moderate risk
Acetylcysteine 10 % Solution
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class II · Moderate risk
Avastin
Lack of Assurance of Sterility; product linked to adverse event reports of endophthalimitis eye infections and FDA inspection findings resulted in concerns regarding quality control processes
Class II · Moderate risk
Sodium Acetate Injection
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
Class II · Moderate risk
QUELICIN (succinylcholine chloride)
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
Class II · Moderate risk
Furosemide Injection
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
Class II · Moderate risk
Diazepam Injection
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
Class II · Moderate risk
0.9% Sodium Chloride Injection
Lack of Assurance of Sterility: The product is being recall due to the product lot being incorrectly released without meeting product specifications. There is the potential for the solution to leak from the administrative port to the fill tube seal.
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.
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 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 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.