Class I · High risk Terminated
Magnesium Sulfate in Water for Injection
Reason Labeling: Incorrect Barcode: Primary bag labeling may be mislabeled with the wrong barcode which scans in as heparin sodium.
FDA Drug Recalls
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Class II · Moderate risk Terminated
Bromfenac Ophthalmic Solution 0.09%
Reason Lack of Assurance of Sterility: Failed preservative effectiveness test
Class III · Low risk Terminated
NORepinephrine Bitartrate
Reason Subpotent Drug; confirmed results by FDA analysis after customer complaints of discoloration
Class III · Low risk Terminated
NORepinephrine Bitartrate
Reason Subpotent Drug; confirmed results by FDA analysis after customer complaints of discoloration
Class III · Low risk Terminated
Candesartan Cilexetil Tablets
Reason Failed Impurities/Degradation Specifications; 9 month stability timepoint
Class II · Moderate risk Terminated
Baclofen
Reason Lack of assurance of sterility
Class II · Moderate risk Terminated
Pramipexole Dihydrochloride Tablets 0.125 mg
Reason Presence of Foreign Tablets/Capsules: Presence of a comingled Carbimazole 5 mg tablet.
Class II · Moderate risk Terminated
IT Custom Compound
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Baclofen 1 mg/ml in 40 ml NS syringe
Reason Lack of Assurance of Sterility
Class I · High risk Terminated
Jenesis Dietary Supplement Capsules
Reason Marketed without an Approved NDA/ANDA; FDA analysis found them to contain sibutramine and phenolphthalein
Class I · High risk Terminated
Oasis Dietary Supplement Capsules
Reason Marketed without an Approved NDA/ANDA; FDA analysis found them to contain sibutramine and phenolphthalein
Class I · High risk Terminated
La' Trim Plus Dietary Supplement Capsules
Reason Marketed without an Approved NDA/ANDA; FDA analysis found them to contain sibutramine and phenolphthalein
Class II · Moderate risk Terminated
Energique
Reason Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count
Class II · Moderate risk Terminated
Energique
Reason Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count
Class II · Moderate risk Terminated
Energique
Reason Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count
Class II · Moderate risk Terminated
Energique
Reason Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count
Class II · Moderate risk Terminated
Energique
Reason Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count
Class II · Moderate risk Terminated
Energique
Reason Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count
Class II · Moderate risk Terminated
Daytrana
Reason Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and z-statistic value which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration.
Class II · Moderate risk Terminated
Daytrana
Reason Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and z-statistic value which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration.
Class II · Moderate risk Terminated
Daytrana
Reason Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and z-statistic value which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration.
Class II · Moderate risk Terminated
Capecitabine tablets USP 500 mg
Reason Failed Dissolution Specifications: low test results at the 18 month time-point
Class III · Low risk Terminated
Life-Line DOCUSATE CALCIUM Sodium Free STOOL SOFTENER 240 mg each
Reason Labeling: Label mix-up. Docusate Sodium 100mg Softgels were mislabeled as Docusate Calcium 240mg.
Class III · Low risk Terminated
Ranitidine Syrup
Reason Failed Impurities/Degradation Specifications: Product recalled due to elevated impurity result detected during routine stability testing.
Class III · Low risk Terminated
VP-CH-PNV PRENATAL/POSTNATAL Prescription Folic Acid-Containing…
Reason Defective Delivery System: Product may contain leaking capsules.