Class II · Moderate risk Terminated
All estriol Products
Reason Lack of Processing Controls
FDA Drug Recalls
11,815 recalls · Class II, newest first
Class II · Moderate risk Terminated
All testosterone Products
Reason Lack of Processing Controls
Class II · Moderate risk Terminated
All 4-aminopyridine Products
Reason Lack of Processing Controls
Class II · Moderate risk Terminated
PerioRx
Reason Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) for an unknown impurity of Chlorhexidine gluconate.
Class II · Moderate risk Terminated
Chlorhexidine gluconate
Reason Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) for an unknown impurity of Chlorhexidine gluconate.
Class II · Moderate risk Terminated
Oris
Reason Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) for an unknown impurity of Chlorhexidine gluconate.
Class II · Moderate risk Terminated
Renovo Patch
Reason Marketed Without An Approved NDA/ANDA: product is an unapproved drug and additionally 3 lots were found to be subpotent.
Class II · Moderate risk Terminated
Dextroamphetamine Sulfate Tablets USP
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Terminated
Dextroamphetamine Sulfate Tablets USP
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Terminated
Formula 2
Reason Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the labeled Beyond Use Date.
Class II · Moderate risk Terminated
Formula 0
Reason Lack of Assurance of Sterility: incomplete or missing data regarding production.
Class II · Moderate risk Terminated
Formula 3
Reason Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the labeled Beyond Use Date.
Class II · Moderate risk Terminated
Formula 1
Reason Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the labeled Beyond Use Date.
Class II · Moderate risk Terminated
Formula 9
Reason Lack of Assurance of Sterility: incomplete or missing data regarding production.
Class II · Moderate risk Terminated
Formula 4
Reason Lack of Assurance of Sterility: incomplete or missing data regarding production.
Class II · Moderate risk Terminated
Formula 2
Reason Superpotent Drug: one ingredient was found to be above assay specification.
Class II · Moderate risk Terminated
Potassium Chloride Injection 20 mEq
Reason Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.
Class II · Moderate risk Terminated
Mannitol I.V.
Reason Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.
Class II · Moderate risk Terminated
Aminosyn-PF
Reason Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.
Class II · Moderate risk Terminated
Dextrose Injection
Reason Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.
Class II · Moderate risk Terminated
Dextrose Injection
Reason Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.
Class II · Moderate risk Terminated
Dextrose Injection
Reason Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.
Class II · Moderate risk Terminated
Zoledronic Acid Injection
Reason Lack of Assurance of Sterility; defective seals where the metal silver ring was not attached tightly to the vial
Class II · Moderate risk Terminated
Fluconazole Injection
Reason Cross contamination with other products: metronidazole
Class II · Moderate risk Terminated
Dextroamphetamine Saccharate
Reason Failed Impurities/Degradation Specifications: Out of specification for impurities.