Class II · Moderate risk
Ciprofloxacin 500 mg tablets
Presence of Foreign Tablets/Capsules: Tramodol 50 mg tablet has been found in a bottle of Ciprofloxacin 500 mg
FDA Drug Recalls
1,273 recalls, newest first
Class III · Low risk
Vasotec (enalapril maleate)
Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of the package insert.
Class III · Low risk
Vaseretic (enalapril maleate/hydrochlorothiazide)
Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of the package outset
Class II · Moderate risk
Isoniazid Tablets
Failed Dissolution Specifications: Stability lots cannot support dissolution past the 36 month time point.
Class II · Moderate risk
Mesalamine
Presence of Particulate Matter: Stainless steel in a chemical reactor dissolved into the API solution and was detected in the finished product.
Class II · Moderate risk
ePHEDrine Sulfate Injection
Labeling: Label Error on Declared Strength; The outer light protective bags, where the ephedrine sulfate injection syringes are stored, were mislabeled with 25 mg/mL in big font and 5 mg/mL in small font, however, the actual syringes were correctly labeled as 25 mg/5 mL.
Class II · Moderate risk
Labetalol Hydrochloride Injection
Presence of Particulate Matter; metal embedded in the glass vial and visible particles floating in the solution
Class II · Moderate risk
Vancomycin Hydrochloride Capsules
Subpotent Drug.
Class III · Low risk
Oasis TEARS
Labeling: Missing Label; The label on the immediate bottle is missing.
Class I · High risk
Coumadin for Injection
Presence of Particulate Matter: particulate matter identified as metallic-like and non-metallic cellulose fiber particles found in retain vials
Class I · High risk
0.9 % Sodium Chloride Injection
Presence of Particulate Matter; blue polyisoprene shavings found inside the bag port tubes
Class II · Moderate risk
Polidocanol 1% Solution for Injection
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Class II · Moderate risk
Pyridoxine HCL
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Class II · Moderate risk
Lipotropic Gold
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Class II · Moderate risk
Papaverine HCl 30 mg
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Class II · Moderate risk
Papaverine HCl 30 mg
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Class II · Moderate risk
Papaverine HCl 30 mg
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Class II · Moderate risk
Papaverine HCl 30 mg
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Class II · Moderate risk
Papaverine HCl 30 mg
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Class II · Moderate risk
B-Complex/Adenosine Inj sol
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Class II · Moderate risk
Papaverine HCl 30 mg
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Class II · Moderate risk
Methylcobalamin for Intramuscular Or Subcutaneous Use Only
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Class II · Moderate risk
Levocarnitine Solution for injection
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Class II · Moderate risk
Mannitol 5% Solution for injection
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Class II · Moderate risk
Mic Plus B12
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.