Class II · Moderate risk
fentaNYL 2 mcg/mL + BUPIvacaine 0.1% PF in 0.9% NS 250 mL
Lack of Assurance of Sterility; product has the potential to leak.
Class II drug recalls - moderate risk
Class II means the product may cause temporary or medically reversible harm, and serious harm is unlikely. It is by far the largest recall class - most potency, dissolution and labeling problems land here.
14,543 recalls, newest first.
Class II · Moderate risk
fentaNYL 10 mcg/mL PF in Sodium Chloride 250 mL
Lack of Assurance of Sterility; product has the potential to leak.
Class II · Moderate risk
fentaNYL 10 mcg/mL PF in NS 1 mL Fill in 3 mL syringe
Lack of Assurance of Sterility; product has the potential to leak.
Class II · Moderate risk
fentaNYL 2 mcg/mL+Bupivacaine 0.0625% PF in 0.9% Sodium Chloride 250 mL
Lack of Assurance of Sterility; product has the potential to leak.
Class II · Moderate risk
fentaNYL as citrate 5 mcg/mL in 0.9% Sodium Chloride 1 mL in Single Dose syringe
Lack of Assurance of Sterility; product has the potential to leak.
Class II · Moderate risk
fentaNYL (as citrate)
Lack of Assurance of Sterility; product has the potential to leak.
Class II · Moderate risk
fentaNYL (as citrate)
Lack of Assurance of Sterility; product has the potential to leak.
Class II · Moderate risk
BUPIVacaine HCl 0.2% IN 0.9% Sodium Chloride 250 mL Bag Preservative Free
Lack of Assurance of Sterility; product has the potential to leak.
Class II · Moderate risk
BUPIVacaine HCl 0.125% In 250 mL 0.9% Sodium Chloride Bag
Lack of Assurance of Sterility; product has the potential to leak.
Class II · Moderate risk
BUPIVacaine HCl 0.1% PF
Lack of Assurance of Sterility; product has the potential to leak.
Class II · Moderate risk
PHENYLephrine HCl 10 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
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.
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