Class III · Low risk Terminated
Oxygen
Reason CGMP Deviations: Cylinders filled using out of date gauges.
FDA Drug Recalls
1,523 recalls · Class III, newest first
Class III · Low risk Terminated
Triamcinolone Diacetate Injectable Suspension
Reason Labeling: Incorrect or Missing Lot and/or Exp Date: some vials may be mislabeled with an incorrect "Compounded" date, lot number, and "Do Not Use Beyond " date or BUD (Before Use Date) that may be longer than intended.
Class III · Low risk Terminated
Clonazepam Tablets
Reason Failed Impurities/Degradation Specifications: out of specification result for known impurity at 6 month timepoint.
Class III · Low risk Terminated
Atorvastatin Calcium 80 mg
Reason Failed Impurities/Degradation Specifications
Class III · Low risk Terminated
Atorvastatin Calcium 40 mg
Reason Failed Impurities/Degradation Specifications
Class III · Low risk Terminated
Atorvastatin Calcium 20 mg
Reason Failed Impurities/Degradation Specifications
Class III · Low risk Terminated
Atorvastatin Calcium 10 mg
Reason Failed Impurities/Degradation Specifications
Class III · Low risk Terminated
Duloxetine Delayed-Release Capsules
Reason Failed Dissolution Specification: Out of specification dissolution results when testing product stability.
Class III · Low risk Terminated
Duloxetine Delayed-Release Capsules
Reason Failed Dissolution Specification: Out of specification dissolution results when testing product stability.
Class III · Low risk Terminated
Duloxetine Delayed-Release Capsules
Reason Failed Dissolution Specification: Out of specification dissolution results when testing product stability.
Class III · Low risk Terminated
Candesartan Cilexetil Tablets
Reason Failed Impurities/Degradation Specifications; 9 month stability (manufacturer)
Class III · Low risk Terminated
Tropicamide Ophthalmic Solution USP
Reason Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.
Class III · Low risk Terminated
Tropicamide Ophthalmic Solution USP
Reason Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.
Class III · Low risk Terminated
Cyclopentolate Hydrochloride Ophthalmic Solution USP
Reason Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.
Class III · Low risk Terminated
Virt-Nate Prenatal/Postnatal
Reason Tablets/Capsules Imprinted with Wrong ID; product debossed with an incorrect punch. Bottles could contain tablets debossed with V259 (debossing for PreTab) instead of the correct punch, V264 (debossing for Virt-Nate).
Class III · Low risk Terminated
risperiDONE ORALLY DISINTEGRATING TABLETS
Reason Failed Impurities/Degradation Specifications: Out of specification for a known degradant.
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 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.
Class III · Low risk Terminated
Lindane Lotion
Reason Super-Potent Drug: Out of Specification Assay test results were reported for stability samples.
Class III · Low risk Terminated
Lumizyme
Reason Labeling: Incorrect or Missing Lot and/or Exp Date
Class III · Low risk Terminated
Quinapril Tablets USP 5 mg
Reason Failed Impurities/Degradation Specifications; Impurity A