Class III · Low risk Terminated
Mozobil
Reason Labeling: Incorrect or Missing Package Insert
FDA Drug Recalls
14,801 recalls, newest first
Class III · Low risk Terminated
Zenatane
Reason Failed Dissolution Specifications
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 III · Low risk Terminated
Selegiline HCL Tablets USP 5mg
Reason Stason Pharmaceuticals is recalling Selegiline HCl tablets, USP 5mg 60 count bottle due to an out of specification result for dissolution of stability samples.
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 III · Low risk Terminated
Lamotrigine Tablets
Reason Tablets/Capsules Imprinted With Wrong ID: incorrect imprint debossed on the tablets.
Class I · High risk Terminated
Lamotrigine Orally Disintegrating Tablets
Reason Labeling; Label Mixup; box labeled to contain 200 mg blister packs but actually contain 100 mg blister packs
Class III · Low risk Terminated
Amoxicillin For Oral Suspension
Reason Labeling: Label Error on Declared Strength- bottles missing colored coded panel where strength of the product is displayed.
Class I · High risk Terminated
Honeywell eyesaline Eyewash Sterile Isotonic Solution
Reason Non Sterility; contaminated with Klebsiella pneumoniae
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.