Class II · Moderate risk
MAGNESIUM Sulfate 4 g added to 100 mL 0.9% Sodium Chloride
Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have the potential to leak.
FDA Drug Recalls
893 recalls · Class II, newest first
Class II · Moderate risk
Diltiazem 125 mg in 0.9% Sodium Chloride
Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have the potential to leak.
Class II · Moderate risk
ceFAZolin 3 g added to 100 mL 0.9% Sodium Chloride
Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have the potential to leak.
Class II · Moderate risk
fentaNYL (as citrate)
Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have the potential to leak.
Class II · Moderate risk
morphine sulfate 1 mg per mL in 0.9% Sodium Chloride
Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have the potential to leak.
Class II · Moderate risk
Testosterone Cypionate + Progesterone
CGMP Deviations
Class II · Moderate risk
0.9% Sodium Chloride Injection
Lack of Assurance of Sterility: Bags have the potential to leak.
Class II · Moderate risk
5% Dextrose Injection
Lack of Assurance of Sterility: Bags have the potential to leak.
Class II · Moderate risk
0.9% Sodium Chloride Injection USP
Lack of Assurance of Sterility: Customer complaints for leaking bags.
Class II · Moderate risk
Carbamazepine Oral Suspension
Labeling Error: Label mix-up. Products' unit dose cups are correctly labeled, but the product carton lists incorrect volume and NDC.
Class II · Moderate risk
parodontax WHITENING
Presence of Foreign Substance: possibility of the presence of metal in the product.
Class II · Moderate risk
Lactulose Solution
Microbial contamination of non-sterile product: product failed Total Yeast/Mold Count specification.
Class II · Moderate risk
Lactulose Solution
Microbial contamination of non-sterile product: product failed Total Yeast/Mold Count specification.
Class II · Moderate risk
Potassium PHOSphate in 5% Dextrose Injection
Lack of Assurance of Sterility; media fill failure at manufacturer
Class II · Moderate risk
Potassium PHOSphate in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility; media fill failure at manufacturer
Class II · Moderate risk
Potassium PHOSphate in 5% Dextrose Injection
Lack of Assurance of Sterility; media fill failure at manufacturer
Class II · Moderate risk
Potassium PHOSphate in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility; media fill failure at manufacturer
Class II · Moderate risk
Potassium PHOSphate in 5% Dextrose Injection
Lack of Assurance of Sterility; media fill failure at manufacturer
Class II · Moderate risk
Potassium PHOSphate in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility; media fill failure at manufacturer
Class II · Moderate risk
Potassium PHOSphate in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility; media fill failure at manufacturer
Class II · Moderate risk
Potassium PHOSphate in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility; media fill failure at manufacturer
Class II · Moderate risk
Potassium PHOSphate in 5% Dextrose Injection
Lack of Assurance of Sterility; media fill failure at manufacturer
Class II · Moderate risk
Potassium PHOSphate in 0.9% Sodium Chloride Injection 20 mMol in…
Lack of Assurance of Sterility; media fill failure at manufacturer
Class II · Moderate risk
Potassium PHOSphate in 0.9% Sodium Chloride Injection 15 mMol in…
Lack of Assurance of Sterility; media fill failure at manufacturer
Class II · Moderate risk
Potassium PHOSphate in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility; media fill failure at manufacturer