Class II · Moderate risk Terminated
Methylcobalamin 1 Mg/Ml
Reason Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Terminated
Methylcobalamin 12.5mg/Ml
Reason Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Class II · Moderate risk Terminated
M.l.C./B5/B6 25 MG/50MG/25MG/10MG/10MG/ML
Reason Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Class II · Moderate risk Terminated
Mb 12/Hxb 12/Fa/P5p/
Reason Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Class II · Moderate risk Terminated
M.l.C. Methyl B12
Reason Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Class II · Moderate risk Terminated
M.I.C. /Mb12/B6/Dexplan/L-Carn
Reason Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Class II · Moderate risk Terminated
M.l.C. 25MG/50MG/25MG/ML
Reason Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Class II · Moderate risk Terminated
L-Glut/L-Arg/L-Carn
Reason Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Class II · Moderate risk Terminated
Levocarnitine 100mg/Ml
Reason Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Class II · Moderate risk Terminated
Hydrogen Peroxide 3%
Reason Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Class II · Moderate risk Terminated
Hcg/Methylcobalamin/Folic Acid
Reason Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Class II · Moderate risk Terminated
1-Hcg 2000 Iu/Ml
Reason Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Class II · Moderate risk Terminated
1-Hcg 1000 Iu/Ml
Reason Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Class II · Moderate risk Terminated
Glutathione 200mg/Ml
Reason Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Class II · Moderate risk Terminated
Glutathione 100mg/Ml
Reason Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Class II · Moderate risk Terminated
GENTAMICIN 15 MG/ML Ophthalmic Solution
Reason Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Class II · Moderate risk Terminated
Estradiol Valerate 40mg/Ml
Reason Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Class II · Moderate risk Terminated
Estradiol Valerate 20mg/Ml
Reason Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Class II · Moderate risk Terminated
Estradiol Valerate 10mg/Ml
Reason Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Class II · Moderate risk Terminated
Estradiol Cypionate 10 Mg/Ml
Reason Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Class II · Moderate risk Terminated
ATROPINE SULFATE 0.5% Ophthalmic Drops
Reason Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Class II · Moderate risk Terminated
Alpha Lipoic Acid 25mg/Ml
Reason Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Class II · Moderate risk Terminated
17-0h Progesterone 250mg/Ml
Reason Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Class II · Moderate risk Terminated
Sulfacetamide Sodium Ophthalmic Solution
Reason Lack of Assurance of Sterility; some lots failed Antimicrobial Effectiveness Testing on stability
Class II · Moderate risk Terminated
Potassium CHLORide added to 5% Dextrose Injection
Reason Labeling: Not Elsewhere Classified: Potassium Chloride was printed on Potassium Phosphate label stock thereby having both names on the label of a 250 mL bag of Potassium Chloride.