US Drug Recall Register

FDA Drug Recalls

14,450 recalls · Class II, newest first

Class II · Moderate risk Terminated

Conzerol

Reason cGMP Deviations

Elroselabs Inc. D-0623-2018
Class II · Moderate risk Terminated

Molleave

Reason cGMP Deviations

Elroselabs Inc. D-0622-2018
Class II · Moderate risk Terminated

Levofloxacin in 5% Dextrose Injection

Reason Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap

AuroMedics Pharma LLC NDC 55150-245-52 D-0709-2018
Class II · Moderate risk Terminated

Levofloxacin in 5% Dextrose Injection

Reason Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap

AuroMedics Pharma LLC NDC 55150-244-47 D-0708-2018
Class II · Moderate risk Terminated

Levetiracetam in 0.54% Sodium Chloride Injection

Reason Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap

AuroMedics Pharma LLC NDC 55150-248-47 D-0707-2018
Class II · Moderate risk Terminated

Levetiracetam in 0.75% Sodium Chloride Injection

Reason Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap

AuroMedics Pharma LLC NDC 55150-247-47 D-0706-2018
Class II · Moderate risk Terminated

Levetiracetam in 0.82% Sodium Chloride Injection

Reason Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap

AuroMedics Pharma LLC NDC 55150-246-47 D-0705-2018
Class II · Moderate risk Terminated

Levofloxacin in 5% Dextrose Injection

Reason Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap

AuroMedics Pharma LLC NDC 55150-243-46 D-0704-2018
Class II · Moderate risk Terminated

Linezolid Injection 600 mg per 300 mL

Reason Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap

AuroMedics Pharma LLC NDC 55150-242-51 D-0703-2018
Class II · Moderate risk Terminated

Testosterone/Finasteride 80 mg/8 mg pellet

Reason Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.

Partell Specialty Pharmacy D-0682-2018
Class II · Moderate risk Terminated

Estradiol 55 mg

Reason Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.

Partell Specialty Pharmacy D-0681-2018
Class II · Moderate risk Terminated

Estradiol 50 mg

Reason Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.

Partell Specialty Pharmacy D-0680-2018
Class II · Moderate risk Terminated

Estradiol 40 mg

Reason Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.

Partell Specialty Pharmacy D-0679-2018
Class II · Moderate risk Terminated

Estradiol 35 mg

Reason Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.

Partell Specialty Pharmacy D-0678-2018
Class II · Moderate risk Terminated

Estradiol 25 mg

Reason Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.

Partell Specialty Pharmacy D-0677-2018
Class II · Moderate risk Terminated

Estradiol 20 mg

Reason Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.

Partell Specialty Pharmacy D-0676-2018
Class II · Moderate risk Terminated

Estradiol 15 mg

Reason Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.

Partell Specialty Pharmacy D-0675-2018
Class II · Moderate risk Terminated

Estradiol 12.5 mg

Reason Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.

Partell Specialty Pharmacy D-0674-2018
Class II · Moderate risk Terminated

Estradiol 10 mg

Reason Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.

Partell Specialty Pharmacy D-0673-2018
Class II · Moderate risk Terminated

Testosterone 80 mg pellet packaged in amber vial

Reason Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.

Partell Specialty Pharmacy D-0669-2018