Class II · Moderate risk
BUPIVacaine HCl 0.1% PF
Lack of Assurance of Sterility; product has the potential to leak.
FDA Drug Recalls
18,003 recalls, newest first
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
Class III · Low risk
Deferoxamine Mesylate for injection
CGMP Deviations: Firm failed to control impurity for color change at the API stage.
Class III · Low risk
Pravastatin Sodium Tablets
Failed Impurities/Degradation Specifications: high out of specification results for related impurity for lot C700220.
Class III · Low risk
Argatroban Injection
Failed Impurities/Degradation Specifications; out of specification result for denitroquinoline-related impurity during three month time point
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 I · High risk
D-ZINE Rapid Size and Strength capsules
Marketed Without An Approved NDA/ANDA: Product contains Methylstenbolone or Dymethazine.
Class I · High risk
ULTRA-STEN Rapid Size and Strength capsules
Marketed Without An Approved NDA/ANDA: Product contains Methylstenbolone or Dymethazine.
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 III · Low risk
Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg 30 tablets per Bottle
Failed Impurities/Degradation Specifications: out of specification test results for related compounds largest unknown impurity.
Class III · Low risk
Buprenorphine and Naloxone Sublingual Tablets
Failed Impurities/Degradation Specifications: out of specification test results for related compounds largest unknown impurity.
Class III · Low risk
Obagi-C Rx System C-Therapy Night Cream
Labeling: Incorrect or Missing Package Insert - Obagi-C Rx System C-Therapy Night Cream is being recalled due to incomplete packaging/labeling. The bottle is missing the product insert and outer carton which contain the complete instruction for use and safety information.
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.