Class II · Moderate risk Terminated
fentaNYL
Reason Lack of Assurance of Sterility; product has the potential to leak.
FDA Drug Recalls
14,801 recalls, newest first
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 III · Low risk Terminated
Halyard 24-Hour Oral Care Kit q4
Reason Crystallization with subpotent out of specification assay results for chlorhexidine.
Class III · Low risk Terminated
Halyard 24-Hour Oral Care Kit q2
Reason Crystallization with subpotent out of specification assay results for chlorhexidine.
Class III · Low risk Terminated
Chlorhexidine Gluconate Oral Rinse
Reason Crystallization with subpotent out of specification assay results for chlorhexidine.
Class II · Moderate risk Terminated
Testosterone Cypionate + Progesterone
Reason CGMP Deviations
Class III · Low risk Terminated
Deferoxamine Mesylate for injection
Reason CGMP Deviations: Firm failed to control impurity for color change at the API stage.
Class III · Low risk Terminated
Pravastatin Sodium Tablets
Reason Failed Impurities/Degradation Specifications: high out of specification results for related impurity for lot C700220.
Class III · Low risk Terminated
Argatroban Injection
Reason Failed Impurities/Degradation Specifications; out of specification result for denitroquinoline-related impurity during three month time point
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 I · High risk Terminated
D-ZINE Rapid Size and Strength capsules
Reason Marketed Without An Approved NDA/ANDA: Product contains Methylstenbolone or Dymethazine.
Class I · High risk Terminated
ULTRA-STEN Rapid Size and Strength capsules
Reason Marketed Without An Approved NDA/ANDA: Product contains Methylstenbolone or Dymethazine.
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 III · Low risk Terminated
Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg 30 tablets per Bottle
Reason Failed Impurities/Degradation Specifications: out of specification test results for related compounds largest unknown impurity.