Class II · Moderate risk
Phenylephrine HCl in 0.9% Sodium Chloride in all strengths
Lack of sterility assurance.
FDA Drug Recalls
893 recalls · Class II, 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 II · Moderate risk
DELFLEX Peritoneal Dialysis Solution
Lack of Assurance of Sterility: Leakage of the peritoneal dialysis (PD) solution 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.
Class II · Moderate risk
Divalproex Sodium Delayed Release Tablets USP
Cross Contamination With Other Products: metronidazole powder was found in one bottle of Divalproex Sodium.
Class II · Moderate risk
Fosphenytoin Sodium Injection
Presence of particulate matter
Class II · Moderate risk
0.25% Acetic Acid Irrigation USP
Presence of Particulate Matter: identified as polyethylene, which is consistent with the material used to manufacture the contain cap