Class II · Moderate risk
ADD HEPARIN PF 50 Units ONLY TO TPN all strengths
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
FDA Drug Recalls
893 recalls · Class II, newest first
Class II · Moderate risk
Early Baby TPN
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Class II · Moderate risk
Early TPN (Neonatal)
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Class II · Moderate risk
Standard Starter TPN all strengths
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Class II · Moderate risk
TPN Neonatal all strengths
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Class II · Moderate risk
NICU STARTER TPN all strengths
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Class II · Moderate risk
Ropi/ Epi/ Clon PeriCapsular injection all strengths
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Class II · Moderate risk
Ofirmev (Acetaminophen)
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Class II · Moderate risk
NOVA PeriCapsular injection all strengths
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Class II · Moderate risk
RECK PeriCapsular injection all strengths
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Class II · Moderate risk
Nalbuphine all strengths
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Class II · Moderate risk
Lidocaine all strengths
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Class II · Moderate risk
Ropivacaine HCl in 0.9% Sodium Chloride all strengths
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Class II · Moderate risk
Bupivacaine HCl in 0.9% Sodium Chloride all strengths
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Class II · Moderate risk
Edex (alprostadil for injection)
Lack of Assurance of Sterility: Defective container resulting in the lack of sterility assurance. ok thanks
Class II · Moderate risk
VANCOMYCIN HCl 1.5g in 300 mL 5% Dextrose Injection USP
Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
Class II · Moderate risk
VANCOMYCIN HCl 1.75g in 300 mL 0.9% Sodium Chloride Injection USP
Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
Class II · Moderate risk
VANCOMYCIN HCl 1.5g in 300 mL 0.9% Sodium Chloride Injection USP
Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
Class II · Moderate risk
Potassium PHOSphate in 0.5% Dextrose
Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
Class II · Moderate risk
Dorama-Neo
Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.
Class II · Moderate risk
Sato Clear
Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.
Class II · Moderate risk
Optic Splash
Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.
Class II · Moderate risk
HealthA2Z CHEWABLE Aspirin
cGMP deviations - presence of rubber particles found loose in the bulk product.
Class II · Moderate risk
Famciclovir tablets
Failed impurities/ degradation specifications: Product was above specification for unknown impurities.
Class II · Moderate risk
Kojic Acid 8%/Azelaic Acid 15% Cream
Lack of Assurance of Sterility: There are also CGMP Deviations.