Class III · Low risk Terminated
Divalproex Sodium Delayed-release Tablets USP
Reason Failed Tablet/Capsule Specifications
FDA Drug Recalls
1,523 recalls · Class III, newest first
Class III · Low risk Terminated
Mycophenolate Mofetil
Reason cGMP deviation; manufacturer is Not Registered with the Food and Drug Administration
Class III · Low risk Terminated
CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15
Reason Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay.
Class III · Low risk Terminated
CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15
Reason Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay.
Class III · Low risk Terminated
CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15
Reason Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay.
Class III · Low risk Terminated
CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15
Reason Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay.
Class III · Low risk Terminated
CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15
Reason Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay.
Class III · Low risk Terminated
CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15
Reason Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay.
Class III · Low risk Terminated
VP-CH-PNV Prenatal/Postnatal capsules
Reason Defective delivery system: Softgel capsules are leaking.
Class III · Low risk Terminated
Pyridoxine HCL 100mg/Ml W/Pres
Reason Lack of Assurance of Sterility
Class III · Low risk Terminated
Hyoscyamine Sulfate Sublingual Tablets
Reason Chemical Contamination: Bottles may contain broken dessicants
Class III · Low risk Terminated
Benzphetamine Hydrochloride Tablets
Reason Discoloration: presence of scuffing marks on tablets.
Class III · Low risk Terminated
Dicloxacillin Sodium Capsules USP
Reason Failed Impurities/Degradation Specifications:Out of specification result for a known impurity obtained during testing.
Class III · Low risk Terminated
Dicloxacillin Sodium Capsules
Reason Failed Impurities/Degradation Specifications:Out of specification result for a known impurity obtained during testing.
Class III · Low risk Terminated
Hectorol
Reason Labeling: Wrong barcode. An incorrect bar code was noted on the vial label of Hectorol 2 mcg/1mL vial.
Class III · Low risk Terminated
CVS pharmacy Original Strength Acid Controller tablets
Reason Failed impurities/degradation specification: An out of specification results has been determined for an individual related substance during stability testing at the 18th month interval for the Famotidine 10 mg Tablet, USP.
Class III · Low risk Terminated
Acetaminophen & Codeine Phosphate Tablets
Reason Labeling: Not elsewhere classified - count on the label was incorrect.
Class III · Low risk Terminated
SKY Aspirin Chewable Tablets
Reason Labeling: Label mix-up -outer carton incorrectly labeled as aspirin chewable tablets.
Class III · Low risk Terminated
BuPROPion Hydrochloride Extended-release Tablets
Reason Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.
Class III · Low risk Terminated
BuPROPion Hydrochloride Extended-release Tablets
Reason Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.
Class III · Low risk Terminated
BuPROPion Hydrochloride Extended-release Tablets
Reason Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.
Class III · Low risk Terminated
Haloperidol Decanoate Injection
Reason Failed Impurities/Degradation Specifications: Firm is recalling product due to an impurity out-of-specification result.
Class III · Low risk Terminated
Lisinopril Tablets USP
Reason CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Class III · Low risk Terminated
Lisinopril Tablets USP
Reason CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Class III · Low risk Terminated
Lisinopril & Hydrochlorothiazide Tables
Reason CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.