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 in 2017
Every FDA drug recall initiated in 2017, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,141 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