Class II · Moderate risk Terminated
Ofirmev
Reason Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Terminated
NOVA PeriCapsular injection all strengths
Reason Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Class II · Moderate risk Terminated
RECK PeriCapsular injection all strengths
Reason Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Class II · Moderate risk Terminated
Nalbuphine all strengths
Reason Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Class II · Moderate risk Terminated
Lidocaine all strengths
Reason Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Class II · Moderate risk Terminated
Ropivacaine HCl in 0.9% Sodium Chloride all strengths
Reason Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Class II · Moderate risk Terminated
Bupivacaine HCl in 0.9% Sodium Chloride all strengths
Reason Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Class II · Moderate risk Terminated
Edex
Reason Lack of Assurance of Sterility: Defective container resulting in the lack of sterility assurance. ok thanks
Class II · Moderate risk Terminated
VANCOMYCIN HCl 1.5g in 300 mL 5% Dextrose Injection USP
Reason Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
Class II · Moderate risk Terminated
VANCOMYCIN HCl 1.75g in 300 mL 0.9% Sodium Chloride Injection USP
Reason Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
Class II · Moderate risk Terminated
VANCOMYCIN HCl 1.5g in 300 mL 0.9% Sodium Chloride Injection USP
Reason Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
Class II · Moderate risk Terminated
Potassium PHOSphate in 0.5% Dextrose
Reason Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
Class II · Moderate risk Terminated
Dorama-Neo
Reason Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.
Class II · Moderate risk Terminated
Sato Clear
Reason Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.
Class II · Moderate risk Terminated
Optic Splash
Reason Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.
Class II · Moderate risk Terminated
HealthA2Z CHEWABLE Aspirin
Reason cGMP deviations - presence of rubber particles found loose in the bulk product.
Class II · Moderate risk Terminated
Famciclovir tablets
Reason Failed impurities/ degradation specifications: Product was above specification for unknown impurities.
Class II · Moderate risk Terminated
Kojic Acid 8%/Azelaic Acid 15% Cream
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk Terminated
Intimate Bleaching Cream
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk Terminated
Gentle Supreme Bleaching Cream
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk Terminated
Custom Lightening/Brightening Cream
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk Terminated
Sulfur 5% Cream
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk Terminated
Sulfacetamide 10%/Hydrocortisone 1% Cream
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk Terminated
Hydrocortisone 2.5% With Aloe Vera Cream
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk Terminated
Metronidazole 1% Gel
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.