Class II · Moderate risk
5% Dextrose and 0.45% Sodium Chloride Injection
Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.
FDA Drug Recalls
11,818 recalls · Class II, newest first
Class II · Moderate risk
5% Dextrose Injection
Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.
Class II · Moderate risk
Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection
Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.
Class II · Moderate risk
Normosol-R pH 7.4 Multiple Electrolytes Injection Type 1
Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.
Class II · Moderate risk
Assured Naproxen Sodium Tablets
Correct Labeled Product Mispacked; correct labeled bottles of Assured Ibuprofen softgels were packaged into cartons of Assured Naproxen Sodium Tablets, USP
Class II · Moderate risk
Glimepiride Tablets
Failed Stability Specifications: Micro Labs is recalling two lots due to out of specification results during stability testing.
Class II · Moderate risk
Dextroamphetamine Saccharate
Failed Impurities/Degradation Specifications: Out of specification for unknown impurities.
Class II · Moderate risk
ZEE Aspirin 325mg - 24 tablets in single dose packets
Incorrect/Undeclared Excipients: ZEE Medical is recalling ZEE Aspirin due to the incorrect listing of inactive ingredients on the product label.
Class II · Moderate risk
Vancomycin Hydrochloride for Injection
Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.
Class II · Moderate risk
Ketorolac Tromethamine Inj.
Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.
Class II · Moderate risk
Vancomycin Hydrochloride for Injection
Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.
Class II · Moderate risk
Vitamin B Complex
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Class II · Moderate risk
Vancomycin
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Class II · Moderate risk
Triesence
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Class II · Moderate risk
Tobramycin
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection
Class II · Moderate risk
Testosterone Cypionate
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Class II · Moderate risk
Testosterone Cypionate
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Class II · Moderate risk
Sodium Chloride Inhalation
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Class II · Moderate risk
Pyridoxine HCL
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Class II · Moderate risk
Procaine HCL
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Class II · Moderate risk
PREDNISOLONE Sodium Phosphate
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Class II · Moderate risk
Papaverine/Phentolamine/Prostaglandin
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Class II · Moderate risk
Papaverine/Phentolamine/Prostaglandin
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Class II · Moderate risk
Papaverine/Phentolamine/Prostaglandin
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection..
Class II · Moderate risk
Papaverine/Phentolamine/Alprostadil
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.