Class II · Moderate risk Terminated
Dextroamphetamine Saccharate
Reason Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
FDA Drug Recalls
14,450 recalls · Class II, newest first
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.
Class II · Moderate risk Terminated
Diocto 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
Aller-Chlor
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
Ninjacof-A
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
Ninjacof
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
Sennazon
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
Pantoprazole Sodium Delayed-Release Tablets USP
Reason Presence of Foreign Tablets/Capsules: Firm received a market complaint stating the presence of one foreign tablet (Montelukast Sodium Chewable Tab 4mg) in the product bottle of Pantoprazole.
Class II · Moderate risk Terminated
Venlafaxine Hydrochloride Extended-Release Capsules
Reason Failed Dissolution Specifications: Out-of-specification results in retained sample.