Class II · Moderate risk
Aripiprazole Tablets
CGMP Deviations: recalling drug products following an FDA inspection.
FDA Drug Recalls
1,356 recalls, newest first
Class II · Moderate risk
Aripiprazole Tablets
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Ohm Sanitizer Spray
CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
Class II · Moderate risk
Ohm Hand Sanitizer
CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
Class II · Moderate risk
Sterile Water for Injection
CGMP Deviations: potential for trace amounts of product carryover.
Class II · Moderate risk
0.9% Sodium Chloride Injection
CGMP Deviations: potential for trace amounts of product carryover.
Class II · Moderate risk
Global Care 70% Alcohol Ethyl Rubbing Alcohol
cGMP Deviations
Class II · Moderate risk
Class II · Moderate risk
Easy Clean 75% Ethyl Alcohol
cGMP Deviations
Class II · Moderate risk
Easy Clean 70% Isopropyl Alcohol
cGMP Deviations
Class II · Moderate risk
Easy Clean Isopropyl Alcohol 99%
cGMP Deviations
Class II · Moderate risk
Class II · Moderate risk
Easy Clean Antiseptic Hand Sanitizer Solution 65% with Glycerine
cGMP Deviations
Class II · Moderate risk
Menastil
cGMP Deviations
Class II · Moderate risk
ProSirona
cGMP Deviations
Class II · Moderate risk
Neuroquell
cGMP Deviations
Class II · Moderate risk
Neuroquell Plus
cGMP Deviations
Class II · Moderate risk
Conzerol zero molluscum contagiosum
CGMP deviations
Class III · Low risk
oxyTOCIN 30 Units/500 mL
Incorrect Product Formulation: Oxytocin 30 units was added to an IV bag of 0.45% Sodium Chloride (500mL) instead of 0.9% Sodium Chloride (500mL).
Class II · Moderate risk
Sanitizing Hand Spray 80%
GMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
Class II · Moderate risk
Triamcinolone Acetonide Cream USP
CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness.
Class II · Moderate risk
Magnesium Citrate SALINE LAXATIVE
CGMP Deviations;
Class II · Moderate risk
Magnesium Citrate SALINE LAXATIVE
CGMP Deviations
Class II · Moderate risk
Magnesium Citrate SALINE LAXATIVE
CGMP Deviations
Class II · Moderate risk
Desmopressin Acetate Tablets
CGMP Deviations