Class II · Moderate risk Terminated
Life-Line tm Catalytic Activated Energy Water
Reason Unapproved new drug
FDA Drug Recalls
14,801 recalls, 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 III · Low risk Terminated
Mometasone Furoate Cream
Reason Labeling: Not Elsewhere Classified. Mometasone Furoate Cream has an NDC typographical error.
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 III · Low risk Terminated
Esomeprazole Magnesium Delayed-Release Capsules USP
Reason Discoloration: Esomeprazole Magnesium DR Capsules (40mg) may contain brown pellets.
Class III · Low risk Terminated
Oxytocin 30 Units added to NS 500 mL
Reason Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented on the label.
Class III · Low risk Terminated
Oxytocin 20 Units added to NS 1000 mL
Reason Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented on the label.
Class III · Low risk Terminated
Oxytocin 10 Units added to NS 1000 mL
Reason Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented on the label.
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 I · High risk Terminated
Levoleucovorin Injection
Reason Presence of Particulate Matter: particulate matter identified as copper salts
Class III · Low risk Terminated
Moxifloxacin Ophthalmic Solution USP
Reason Failed Impurities/Degradation Specifications: Out of specification test results in related substance at three-month long term stability study was obtained.
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 III · Low risk Terminated
Diltiazem HCl CD capsules
Reason Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
Class III · Low risk Terminated
Cardizem CD
Reason Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.