Class II · Moderate risk Terminated
5% Dextrose Injection
Reason Lack of Assurance of Sterility: Bags have the potential to leak.
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Terminated
0.9% Sodium Chloride Injection USP
Reason Lack of Assurance of Sterility: Customer complaints for leaking bags.
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 II · Moderate risk Terminated
parodontax WHITENING
Reason Presence of Foreign Substance: possibility of the presence of metal in the product.
Class II · Moderate risk Terminated
Lactulose Solution
Reason Microbial contamination of non-sterile product: product failed Total Yeast/Mold Count specification.
Class II · Moderate risk Terminated
Lactulose Solution
Reason Microbial contamination of non-sterile product: product failed Total Yeast/Mold Count specification.
Class II · Moderate risk Terminated
Potassium PHOSphate in 5% Dextrose Injection
Reason Lack of Assurance of Sterility; media fill failure at manufacturer
Class II · Moderate risk Terminated
Potassium PHOSphate in 0.9% Sodium Chloride Injection
Reason Lack of Assurance of Sterility; media fill failure at manufacturer
Class II · Moderate risk Terminated
Potassium PHOSphate in 5% Dextrose Injection
Reason Lack of Assurance of Sterility; media fill failure at manufacturer
Class II · Moderate risk Terminated
Potassium PHOSphate in 0.9% Sodium Chloride Injection
Reason Lack of Assurance of Sterility; media fill failure at manufacturer
Class II · Moderate risk Terminated
Potassium PHOSphate in 5% Dextrose Injection
Reason Lack of Assurance of Sterility; media fill failure at manufacturer
Class II · Moderate risk Terminated
Potassium PHOSphate in 0.9% Sodium Chloride Injection
Reason Lack of Assurance of Sterility; media fill failure at manufacturer
Class II · Moderate risk Terminated
Potassium PHOSphate in 0.9% Sodium Chloride Injection
Reason Lack of Assurance of Sterility; media fill failure at manufacturer
Class II · Moderate risk Terminated
Potassium PHOSphate in 0.9% Sodium Chloride Injection
Reason Lack of Assurance of Sterility; media fill failure at manufacturer
Class II · Moderate risk Terminated
Potassium PHOSphate in 5% Dextrose Injection
Reason Lack of Assurance of Sterility; media fill failure at manufacturer
Class II · Moderate risk Terminated
Potassium PHOSphate in 0.9% Sodium Chloride Injection 20 mMol in…
Reason Lack of Assurance of Sterility; media fill failure at manufacturer
Class II · Moderate risk Terminated
Potassium PHOSphate in 0.9% Sodium Chloride Injection 15 mMol in…
Reason Lack of Assurance of Sterility; media fill failure at manufacturer
Class II · Moderate risk Terminated
Potassium PHOSphate in 0.9% Sodium Chloride Injection
Reason Lack of Assurance of Sterility; media fill failure at manufacturer
Class II · Moderate risk Terminated
Succinylcholine Chloride Injection
Reason Lack of Assurance of Sterility; media fill failure at manufacturer
Class II · Moderate risk Terminated
Timolol-Brimonidine-Dorzolamide-Latanoprost
Reason Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier
Class II · Moderate risk Terminated
Timolol-Latanoprost PF Solution
Reason Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier
Class II · Moderate risk Terminated
Latanoprost PF Solution
Reason Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier
Class II · Moderate risk Terminated
Curcumin Emulsion 10mg/ml Injection
Reason Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier
Class II · Moderate risk Terminated
Potassium Phosphate
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Potassium Phosphate
Reason Lack of Assurance of Sterility