Class II · Moderate risk
EPINEPHrine HCl 4 mg in 0.9% Sodium Chloride 250 mL
Lack of Assurance of Sterility; product has the potential to leak.
FDA Drug Recalls
1,134 recalls, newest first
Class II · Moderate risk
ePHEDrine Sulfate 5 mg/mL in NS 5 mL Fill in 12 mL Syringe
Lack of Assurance of Sterility; product has the potential to leak.
Class II · Moderate risk
Hydromorphone 0.5 mg/mL in 0.9% Sodium Chloride 1 mL Fill in 3 mL BD syringe
Lack of Assurance of Sterility; product has the potential to leak.
Class II · Moderate risk
fentaNYL 3 mcg/mL + BUPIvacaine 0.1% in 0.9% Sodium Chloride 250 mL
Lack of Assurance of Sterility; product has the potential to leak.
Class II · Moderate risk
fentaNYL 2 mcg/mL + BUPIvacaine 0.125% PF in 0.9% Sodium Chloride 250 mL
Lack of Assurance of Sterility; product has the potential to leak.
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 · 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 III · Low risk
Halyard 24-Hour Oral Care Kit q4
Crystallization with subpotent out of specification assay results for chlorhexidine.
Class III · Low risk
Halyard 24-Hour Oral Care Kit q2
Crystallization with subpotent out of specification assay results for chlorhexidine.
Class III · Low risk
Chlorhexidine Gluconate Oral Rinse
Crystallization with subpotent out of specification assay results for chlorhexidine.
Class II · Moderate risk
Testosterone Cypionate + Progesterone
CGMP Deviations