Class II · Moderate risk Terminated
fentaNYL 10 mcg/mL PF in NS 1 mL Fill in 3 mL syringe
Reason Lack of Assurance of Sterility; product has the potential to leak.
FDA Drug Recalls
11,815 recalls · Class II, newest first
Class II · Moderate risk Terminated
fentaNYL 2 mcg/mL+Bupivacaine 0.0625% PF in 0.9% Sodium Chloride 250 mL
Reason Lack of Assurance of Sterility; product has the potential to leak.
Class II · Moderate risk Terminated
fentaNYL as citrate 5 mcg/mL in 0.9% Sodium Chloride 1 mL in Single Dose syringe
Reason Lack of Assurance of Sterility; product has the potential to leak.
Class II · Moderate risk Terminated
fentaNYL
Reason Lack of Assurance of Sterility; product has the potential to leak.
Class II · Moderate risk Terminated
fentaNYL
Reason Lack of Assurance of Sterility; product has the potential to leak.
Class II · Moderate risk Terminated
BUPIVacaine HCl 0.2% IN 0.9% Sodium Chloride 250 mL Bag Preservative Free
Reason Lack of Assurance of Sterility; product has the potential to leak.
Class II · Moderate risk Terminated
BUPIVacaine HCl 0.125% In 250 mL 0.9% Sodium Chloride Bag
Reason Lack of Assurance of Sterility; product has the potential to leak.
Class II · Moderate risk Terminated
BUPIVacaine HCl 0.1% PF
Reason Lack of Assurance of Sterility; product has the potential to leak.
Class II · Moderate risk Terminated
PHENYLephrine HCl 10 mg in 0.9% Sodium Chloride
Reason Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have the potential to leak.
Class II · Moderate risk Terminated
MAGNESIUM Sulfate 4 g added to 100 mL 0.9% Sodium Chloride
Reason Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have the potential to leak.
Class II · Moderate risk Terminated
Diltiazem 125 mg in 0.9% Sodium Chloride
Reason Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have the potential to leak.
Class II · Moderate risk Terminated
ceFAZolin 3 g added to 100 mL 0.9% Sodium Chloride
Reason Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have the potential to leak.
Class II · Moderate risk Terminated
fentaNYL
Reason Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have the potential to leak.
Class II · Moderate risk Terminated
morphine sulfate 1 mg per mL in 0.9% Sodium Chloride
Reason Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have the potential to leak.
Class II · Moderate risk Terminated
Testosterone Cypionate + Progesterone
Reason CGMP Deviations
Class II · Moderate risk Terminated
0.9% Sodium Chloride Injection
Reason Lack of Assurance of Sterility: Bags have the potential to leak.
Class II · Moderate risk Terminated
5% Dextrose Injection
Reason Lack of Assurance of Sterility: Bags have the potential to leak.
Class II · Moderate risk Terminated
0.9% Sodium Chloride Injection USP
Reason Lack of Assurance of Sterility: Customer complaints for leaking bags.
Class II · Moderate risk Terminated
Carbamazepine Oral Suspension
Reason 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 Terminated
parodontax WHITENING
Reason Presence of Foreign Substance: possibility of the presence of metal in the product.
Class II · Moderate risk Terminated
Lactulose Solution
Reason Microbial contamination of non-sterile product: product failed Total Yeast/Mold Count specification.
Class II · Moderate risk Terminated
Lactulose Solution
Reason Microbial contamination of non-sterile product: product failed Total Yeast/Mold Count specification.
Class II · Moderate risk Terminated
Potassium PHOSphate in 5% Dextrose Injection
Reason Lack of Assurance of Sterility; media fill failure at manufacturer
Class II · Moderate risk Terminated
Potassium PHOSphate in 0.9% Sodium Chloride Injection
Reason Lack of Assurance of Sterility; media fill failure at manufacturer
Class II · Moderate risk Terminated
Potassium PHOSphate in 5% Dextrose Injection
Reason Lack of Assurance of Sterility; media fill failure at manufacturer