Class III · Low risk
Deferoxamine Mesylate for injection
CGMP Deviations: Firm failed to control impurity for color change at the API stage.
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 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.
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
Class II · Moderate risk
Potassium PHOSphate in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility; media fill failure at manufacturer
Class II · Moderate risk
Potassium PHOSphate in 5% Dextrose Injection
Lack of Assurance of Sterility; media fill failure at manufacturer
Class II · Moderate risk
Potassium PHOSphate in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility; media fill failure at manufacturer
Class II · Moderate risk
Potassium PHOSphate in 5% Dextrose Injection
Lack of Assurance of Sterility; media fill failure at manufacturer
Class II · Moderate risk
Potassium PHOSphate in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility; media fill failure at manufacturer
Class II · Moderate risk
Potassium PHOSphate in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility; media fill failure at manufacturer
Class II · Moderate risk
Potassium PHOSphate in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility; media fill failure at manufacturer
Class II · Moderate risk
Potassium PHOSphate in 5% Dextrose Injection
Lack of Assurance of Sterility; media fill failure at manufacturer
Class II · Moderate risk
Potassium PHOSphate in 0.9% Sodium Chloride Injection 20 mMol in…
Lack of Assurance of Sterility; media fill failure at manufacturer