Class II · Moderate risk Terminated
Methylcobalamin 5000 mcg/mL Injection
Reason Lack of Assurance of Sterility; medication was sterilized with a recalled filter
FDA Drug Recalls
11,815 recalls · Class II, newest first
Class II · Moderate risk Terminated
Ondansetron HCI API
Reason Microbial Contamination of Non-Sterile Product
Class II · Moderate risk Terminated
Eye Wash
Reason Lack of assurance of sterility
Class II · Moderate risk Terminated
Eye Wash
Reason Lack of assurance of sterility
Class II · Moderate risk Terminated
Eye Irrigating Solution
Reason Lack of assurance of sterility
Class II · Moderate risk Terminated
Phenylephrine HCI Injection
Reason Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that product sterility may be compromised.
Class II · Moderate risk Terminated
Ephedrine Sulfate Injection
Reason Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that product sterility may be compromised.
Class II · Moderate risk Terminated
Dextroamphetamine Saccharate
Reason Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Class II · Moderate risk Terminated
Dextroamphetamine Saccharate
Reason Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Class II · Moderate risk Terminated
Dextroamphetamine Saccharate
Reason Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Class II · Moderate risk Terminated
Dextroamphetamine Saccharate
Reason Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Class II · Moderate risk Terminated
Dextroamphetamine Saccharate
Reason Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Class II · Moderate risk Terminated
Dextroamphetamine Saccharate
Reason Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Class II · Moderate risk Terminated
Dextroamphetamine Saccharate
Reason Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Class II · Moderate risk Terminated
Dextroamphetamine Saccharate
Reason Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Class II · Moderate risk Terminated
Dextroamphetamine Saccharate
Reason Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Class II · Moderate risk Terminated
Dextroamphetamine Saccharate
Reason Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Class II · Moderate risk Terminated
Transderm Scop
Reason Defective Delivery System; reports of damaged product that may alter the predicted release of scopolamine following transdermal application.
Class II · Moderate risk Terminated
Daytrana
Reason Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and and/or the z-statistic values.
Class II · Moderate risk Terminated
Daytrana
Reason Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and and/or the z-statistic values.
Class II · Moderate risk Terminated
Daytrana
Reason Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and and/or the z-statistic values.
Class II · Moderate risk Terminated
DOBUTamine Injection
Reason Discoloration: Firm received complaints of product discoloration and particulates.
Class II · Moderate risk Terminated
Ephedrine Sulfate Injection
Reason Lack of Assurance of Sterility: An FDA inspection at the facility raised concerns that product sterility was potentially impacted.
Class II · Moderate risk Terminated
Senna Syrup
Reason CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
Class II · Moderate risk Terminated
Senexon Liquid
Reason CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.