Class II · Moderate risk Terminated
PAP/PHEN/PGE1 22 mg/0.8mg/8mcg/mL Injection
Reason Lack of Assurance of Sterility.
FDA Drug Recalls
14,801 recalls, newest first
Class II · Moderate risk Terminated
Methylcobalamin 10 mg/mL Injection
Reason Lack of Assurance of Sterility.
Class II · Moderate risk Terminated
Methylcobalamin 1 mg/mL Injection
Reason Lack of Assurance of Sterility.
Class II · Moderate risk Terminated
Hydroxocobalamin 10 mg/mL Injection
Reason Lack of Assurance of Sterility.
Class II · Moderate risk Terminated
Prostaglandin 20 mcg/mL/Procaine 0.1% Injection
Reason Lack of Assurance of Sterility.
Class II · Moderate risk Terminated
Hydroxyprogesterone Caproate 250 mg/mL Sesame Oil Injection
Reason Lack of Assurance of Sterility.
Class II · Moderate risk Terminated
Testosterone Cyp/Estradiol Cyp 50 mg/2.5 mg/mL Injection
Reason Lack of Assurance of Sterility.
Class II · Moderate risk Terminated
Testosterone Cypionate 100 mg/mLOil Injection Injection
Reason Lack of Assurance of Sterility.
Class II · Moderate risk Terminated
Testosterone Cypionate 200 mg/mL Ethyl Oleate Injection
Reason Lack of Assurance of Sterility.
Class II · Moderate risk Terminated
Testosterone Cypionate 200 mg/mL Sesame Oil Injection
Reason Lack of Assurance of Sterility.
Class II · Moderate risk Terminated
Testosterone Cypionate 150 mg/mL Sesame Oil Injection
Reason Lack of Assurance of Sterility.
Class II · Moderate risk Terminated
Testosterone Cypionate 100 mg/mL Sesame Oil Injection
Reason Lack of Assurance of Sterility.
Class III · Low risk Terminated
Smart Sense Regular Strength Aspirin Tablets
Reason Labeling; Incorrect or Missing Lot Number and/or Exp Date; Product has an incorrect expiration date of 9/2022 applied to the labeling, where the actual expiration date is 10/2021.
Class II · Moderate risk Terminated
Diphenhydramine HCL Liquid
Reason Microbial Contamination of Non-sterile Products: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk Terminated
Acetaminophen Children's Liquid
Reason Microbial Contamination of Non-sterile Products: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk Terminated
Workvie Instant Pain Relieving Roll On
Reason CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Class II · Moderate risk Terminated
Neogen-D
Reason CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Class II · Moderate risk Terminated
Sorbugen Nr
Reason CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Class II · Moderate risk Terminated
Tusslin
Reason CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Class II · Moderate risk Terminated
Dayma SUPER FORTE XL10
Reason CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Class II · Moderate risk Terminated
Lid O Creme
Reason CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Class II · Moderate risk Terminated
Lido E.R.
Reason CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Class II · Moderate risk Terminated
Dermanak original crema blanqueador
Reason CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Class II · Moderate risk Terminated
LidoAID
Reason CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Class II · Moderate risk Terminated
Double Tussin Dm
Reason CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.