Class II · Moderate risk
Papaverine HCl 30 mg
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
FDA Drug Recalls
5,405 recalls, newest first
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.
Class II · Moderate risk
Testosterone Cypionate for Injection
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Class II · Moderate risk
Polidocanol 5% Solution for Injection
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Class II · Moderate risk
Cyanocobalamin 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
Liver Derivative Complex for injection
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Class II · Moderate risk
Polidocanol 0.5% Solution for Injection
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Class II · Moderate risk
Gemcitabine For Injection USP
Lack of Assurance of Sterility: A particle excursion for a different batch of the same product may lead to a lack of sterility assurance.
Class II · Moderate risk
ParaGard T 380A - Intrauterine Copper Contraceptive
Non-sterility: due to a failed sterility test
Class II · Moderate risk
Zoledronic Acid Injection 5 mg per 100 mL
Lack of Assurance of Sterility; leaking of premix bags
Class II · Moderate risk
All sterile drugs compounded between 2/21/14 and 2/24/14.
Lack of Assurance of Sterility: All compounded products.
Class I · High risk
Dianeal PD-2 Peritoneal Dialysis Solution with 1.5% Dextrose
Non-Sterility: Complaints of leaks and particulate matter identified as mold in the solution bag and the overpouch.
Class II · Moderate risk
0.9% Sodium Chloride Injection
Lack of Assurance of Sterility:Solution leaking through the port cover of the primary container, which was identified during a retain sample visual inspection.
Class II · Moderate risk
ROHTO Redness Relief
Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief and Rohto Cool eye drops, due to concerns related to the quality assurance of sterility controls.
Class II · Moderate risk
ROHTO Cooling Eye Drops
Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief and Rohto Cool eye drops, due to concerns related to the quality assurance of sterility controls.
Class II · Moderate risk
ROHTO Dry Eye
Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief and Rohto Cool eye drops, due to concerns related to the quality assurance of sterility controls.