Class II · Moderate risk
Phenylephrine HCl in 0.9% Sodium Chloride in all strengths
Lack of sterility assurance.
FDA drug recalls in 2017
Every FDA drug recall initiated in 2017, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,141 recalls, newest first.
Class II · Moderate risk
Dexamethasone Sodium Phosphate in all strengths
Lack of sterility assurance.
Class II · Moderate risk
Adenosine Injection in all strengths
Lack of sterility assurance.
Class II · Moderate risk
Succinylcholine Chloride in all strengths
Lack of sterility assurance.
Class II · Moderate risk
Ketamine HCl in 0.9% Sodium Chloride in all strengths
Lack of sterility assurance.
Class II · Moderate risk
Potassium Chloride in 0.9% Sodium Chloride in all strengths
Lack of sterility assurance.
Class II · Moderate risk
Fentanyl Citrate in 0.9% Sodium Chloride in all strengths
Lack of sterility assurance.
Class II · Moderate risk
Lidocaine HCl in all strengths
Lack of sterility assurance.
Class II · Moderate risk
Morphine Sulfate in 5% Dextrose in all strengths
Lack of sterility assurance.
Class II · Moderate risk
Morphine Sulfate in 0.9% Sodium Chloride in all strengths
Lack of sterility assurance.
Class II · Moderate risk
Midazolam HCl in 5% Dextrose in all strengths
Lack of sterility assurance.
Class II · Moderate risk
Midazolam HCl in 0.9% Sodium Chloride in all strengths
Lack of sterility assurance.
Class II · Moderate risk
HYDROmorphone HCl Injection in all strengths
Lack of sterility assurance.
Class II · Moderate risk
Ephedrine Sulfate in 0.9% Sodium Chloride in all strengths
Lack of sterility assurance.
Class II · Moderate risk
Fentanyl Citrate and Bupivacaine HCl in 0.9% Sodium Chloride in all strengths
Lack of sterility assurance.
Class II · Moderate risk
Fentanyl Citrate and Ropivacaine HCl in 0.9% Sodium Chloride in all strengths
Lack of sterility assurance.
Class II · Moderate risk
Bupivacaine HCl in 0.9% Sodium Chloride in all doses
Lack of sterility assurance.
Class II · Moderate risk
HYDROmorphone HCl in Sodium Chloride 0.9% in all doses
Lack of sterility assurance.
Class II · Moderate risk
Famciclovir Tablets
Temperature Abuse: Complaints of tablets being wet and stuck together with tablet coating peeled and disintegrated as a result of prolonged exposure to high temp during distribution.
Class III · Low risk
Simvastatin Tablets
Presence of foreign substance: metallic razor blade was found in one bottle.
Class III · Low risk
Clobetasol Propionate Cream USP
Failed Content Uniformity Specifications
Class II · Moderate risk
DELFLEX Peritoneal Dialysis Solution
Lack of Assurance of Sterility: Leakage of the peritoneal dialysis (PD) solution bag.
Class I · High risk
Linezolid Injection 600 mg/300 mL
Presence of Particulate Matter; white particulate matter identified as mold was found in one bag
Class II · Moderate risk
Dry to Normal Skin Starter Kit
Failed Stability Specifications:stability failure at 12 months, long term RT conditions.
Class II · Moderate risk
Day Cream SPF15 Cr¿me de jour FPS 15
Failed Stability Specifications:stability failure at 12 months, long term RT conditions.