Class II · Moderate risk
Cefdinir for Oral Suspension USP
CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick.
FDA Drug Recalls
14,806 recalls, newest first
Class II · Moderate risk
Cefdinir for Oral Suspension USP
CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick.
Class II · Moderate risk
0.9% Buffered Lidocaine HCl
Subpotent
Class II · Moderate risk
Cidofovir Injection 375mg/5mL
Lack of Assurance of Sterility: complaints received about dried powder on the outside of bottle
Class II · Moderate risk
Dianeal Low Calcium
Lack of Assurance of Sterility: Confirmed customer complaints for leaks on the tubing.
Class III · Low risk
Loperamide HCL Tablets USP
Labeling Not Elsewhere Classified: The front panel indicates 24 caplets whereas the side panel indicates 12 caplets. The drug product carton contains 24 caplets.
Class II · Moderate risk
Estradiol Vaginal Inserts
Defective Delivery System: Customer complaints of malfunctioning plunger of the applicator
Class II · Moderate risk
Nitrofurantoin Oral Suspension
Subpotent Drug: Expansion of June 2018 recall of lots S700065 and S700619 due to below specification results for assay.
Class III · Low risk
COSOPT Ophthalmic Solution
Failed Stability Specifications: out of specification results for opalescence at 7 month stability study.
Class I · High risk
Ceftriaxone for Injection USP
Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.
Class I · High risk
Ceftriaxone for Injection USP
Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.
Class I · High risk
Ceftriaxone for Injection USP
Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.
Class I · High risk
Ceftriaxone for Injection USP
Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.
Class III · Low risk
Temozolomide Capsules
Failed Dissolution Specifications
Class III · Low risk
Temozolomide Capsules
Failed Dissolution Specifications
Class II · Moderate risk
Oxygen
CGMP Deviations
Class II · Moderate risk
Olmesartan Medoxomil and Hydrochlorothiazide Tablets
Failed dissolution specifications
Class II · Moderate risk
Cidofovir Dihydrate
CGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.
Class II · Moderate risk
Folic Acid
Lack of sterility assurance.
Class II · Moderate risk
Zinc Sulfate
Lack of sterility assurance.
Class II · Moderate risk
Glycyrrhizic Acid
Lack of sterility assurance.
Class II · Moderate risk
Dexpanthenol
Lack of sterility assurance.
Class II · Moderate risk
Lysine HCl
Lack of sterility assurance.
Class II · Moderate risk
Leucine/Isoleucine/Valine injection
Lack of sterility assurance.
Class II · Moderate risk
Pyridoxine HCl
Lack of sterility assurance.