Class II · Moderate risk
Lactated Ringer's 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
14,806 recalls, newest first
Class II · Moderate risk
5% Dextrose and 0.9% 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
Lactated Ringer's and 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
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
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 III · Low risk
TORISEL Kit
Crystallization: Impurities in a raw material used to manufacture the diluent can cause the formation of crystals in the diluent vials after cold storage. The TORISEL vials are not affected by this issue.
Class III · Low risk
MethylPREDNISolone Tablets
Subpotent; 6 month stability time point
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 I · High risk
Propofol Injectable Emulsion
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.