Class II · Moderate risk Terminated
Life-Line tm Catalytic Activated Energy Water
Reason Unapproved new drug
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Terminated
Indian Herb Paste
Reason Unapproved new drug
Class II · Moderate risk Terminated
MAGnesium 2 gm sulfate
Reason Labeling: Incorrect or Missing Lot and/or Exp Date:The product labels contain a Two-Dimensional ( 2D ) barcode that, when scanned, reveals information specific to the batch of the labeled product, including Expiration Date. The expiration date included within these 2D barcodes is incorrect and does not match the correct expiration date listed on the face of the label itself.
Class II · Moderate risk Terminated
MAGnesium 2gm sulfate
Reason Labeling: Incorrect or Missing Lot and/or Exp Date:The product labels contain a Two-Dimensional ( 2D ) barcode that, when scanned, reveals information specific to the batch of the labeled product, including Expiration Date. The expiration date included within these 2D barcodes is incorrect and does not match the correct expiration date listed on the face of the label itself.
Class II · Moderate risk Terminated
MAGnesium 1gm sulfate
Reason Labeling: Incorrect or Missing Lot and/or Exp Date:The product labels contain a Two-Dimensional ( 2D ) barcode that, when scanned, reveals information specific to the batch of the labeled product, including Expiration Date. The expiration date included within these 2D barcodes is incorrect and does not match the correct expiration date listed on the face of the label itself.
Class II · Moderate risk Terminated
Labetalol 20mg
Reason Labeling: Incorrect or Missing Lot and/or Exp Date:The product labels contain a Two-Dimensional ( 2D ) barcode that, when scanned, reveals information specific to the batch of the labeled product, including Expiration Date. The expiration date included within these 2D barcodes is incorrect and does not match the correct expiration date listed on the face of the label itself.
Class II · Moderate risk Terminated
Express Gel Hand Sanitizer
Reason Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.
Class II · Moderate risk Terminated
Quick-Care Foam Hand Sanitizer
Reason Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.
Class II · Moderate risk Terminated
Moisturizing Gel Hand Sanitizer
Reason Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.
Class II · Moderate risk Terminated
Advanced Gel Hand Sanitizer
Reason Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.
Class II · Moderate risk Terminated
Gel Hand Sanitizer
Reason Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.
Class II · Moderate risk Terminated
Fentanyl in 0.9% Sodium Chloride QS 0.5 mL
Reason Labeling: Incorrect expiration date.
Class II · Moderate risk Terminated
Moisturizing Lubricant Eye Drops
Reason Failed Stability Specification: out of specification results for Sodium Perborate
Class II · Moderate risk Terminated
0.9% Sodium Chloride Injection
Reason CGMP Deviations
Class II · Moderate risk Terminated
Dymista
Reason Defective Container: Potential for broken glass in the neck area of the glass bottles.
Class II · Moderate risk Terminated
Divalproex Sodium Extended-release Tablets
Reason Failed Dissolution Specifications: Out of specification results observed for high dissolution.
Class II · Moderate risk Terminated
Ephedrine Sulfate
Reason Lack of assurance of sterility.
Class II · Moderate risk Terminated
LET Gel 4%
Reason Labeling: Incorrect or Missing Lot and/or Exp Date: Labels are missing lot and expiration date and are printed as Lot# YYYDDYY@XX with a Beyond Use Date: MM/DD/YYY.
Class II · Moderate risk Terminated
BromSite
Reason Bromfenac Ophthalmic Solution, 0.075% (Sterile 5 mL) may have a lack of sterility assurance.
Class II · Moderate risk Terminated
Alprazolam Tablets
Reason Failed Impurities/Degradation Specifications: Elevated levels of a known impurity detected during 6-month RT stability interval.
Class II · Moderate risk Terminated
Fexofenadine HCl Tablets
Reason Failed Impurities/Degradation Specifications: Related compound results obtained during routine stability testing was slightly elevated above specification.
Class II · Moderate risk Completed
Irbesartan and Hydrochlorothiazide Tablets
Reason CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Class II · Moderate risk Completed
Irbesartan and Hydrochlorothiazide Tablets
Reason CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Class II · Moderate risk Completed
Irbesartan and Hydrochlorothiazide Tablets
Reason CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Class II · Moderate risk Completed
Irbesartan and HydrochlorothiazideTablets
Reason CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.