Class III · Low risk
Oxycodone HCl
Failed Impurities/Degradation Specification; 9 month stability
FDA Drug Recalls
1,525 recalls · Class III, newest first
Class III · Low risk
Doxycycline
Labeling: Incorrect Or Missing Lot and/or Exp Date: Some expiries and lot numbers are missing.
Class III · Low risk
Divalproex Sodium Delayed-release Tablets USP
Failed Tablet/Capsule Specifications
Class III · Low risk
Mycophenolate Mofetil
cGMP deviation; manufacturer is Not Registered with the Food and Drug Administration
Class III · Low risk
CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15
Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay.
Class III · Low risk
CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15
Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay.
Class III · Low risk
CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15
Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay.
Class III · Low risk
CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15
Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay.
Class III · Low risk
CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15
Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay.
Class III · Low risk
CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15
Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay.
Class III · Low risk
VP-CH-PNV Prenatal/Postnatal capsules
Defective delivery system: Softgel capsules are leaking.
Class III · Low risk
Pyridoxine HCL 100mg/Ml W/Pres
Lack of Assurance of Sterility
Class III · Low risk
Hyoscyamine Sulfate Sublingual Tablets
Chemical Contamination: Bottles may contain broken dessicants
Class III · Low risk
Benzphetamine Hydrochloride Tablets
Discoloration: presence of scuffing marks on tablets.
Class III · Low risk
Dicloxacillin Sodium Capsules USP
Failed Impurities/Degradation Specifications:Out of specification result for a known impurity obtained during testing.
Class III · Low risk
Dicloxacillin Sodium Capsules
Failed Impurities/Degradation Specifications:Out of specification result for a known impurity obtained during testing.
Class III · Low risk
Hectorol (doxercalciferol injection)
Labeling: Wrong barcode. An incorrect bar code was noted on the vial label of Hectorol 2 mcg/1mL vial.
Class III · Low risk
CVS pharmacy Original Strength Acid Controller tablets
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
Acetaminophen & Codeine Phosphate Tablets
Labeling: Not elsewhere classified - count on the label was incorrect.
Class III · Low risk
SKY Aspirin Chewable Tablets
Labeling: Label mix-up -outer carton incorrectly labeled as aspirin chewable tablets.
Class III · Low risk
BuPROPion Hydrochloride Extended-release Tablets
Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.
Class III · Low risk
BuPROPion Hydrochloride Extended-release Tablets
Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.
Class III · Low risk
BuPROPion Hydrochloride Extended-release Tablets
Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.
Class III · Low risk
Haloperidol Decanoate Injection
Failed Impurities/Degradation Specifications: Firm is recalling product due to an impurity out-of-specification result.
Class III · Low risk
Lisinopril Tablets USP
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.