Class II · Moderate risk Terminated
Testosterone Cypionate 200 mg/mL Ethyl Oleate Injection
Reason Lack of Assurance of Sterility.
FDA Drug Recalls
17,898 recalls, newest first
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.
Class II · Moderate risk Terminated
Gencontuss
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
ARMY HEALTH Pain Reliever Gel With CURCUMIN
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
Oliver's Harvest CBD+Lidocaine HCL 4% Pain Relief
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
ARMY HEALTH With CURCUMIN
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
AbeeMed cream
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
Oliver's Harvest CBD+Capsaicin 0.2% Pain Relief
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
Losartan Potassium andHydrochlorothiazide Tablets 100 mg/25 mg 90 tablets
Reason CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Class II · Moderate risk Terminated
Losartan Potassium and Hydrochlorothiazide Tablets
Reason CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.