Class II · Moderate risk Terminated
No. 1 Faiza Beauty Cream Manufactured by: Poonia Brothers
Reason Marketed Without an Approved NDA/ANDA
FDA Drug Recalls
14,801 recalls, newest first
Class III · Low risk Terminated
Enalapril Maleate tablets
Reason Failed Impurities/Degradation Specifications: 5mg strength being recalled for out of specification results for related compound.
Class II · Moderate risk Terminated
Paroxetine tablets USP
Reason Presence of Foreign tablets/capsules: risperidone Tablets were found in bottle of paroxetine Tablets
Class III · Low risk Terminated
Hydrocodone Bitartrate and Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL
Reason Labeling: Not Elsewhere Classified; product is incorrectly labeled as Class III controlled substance instead of Class II controlled substance
Class II · Moderate risk Terminated
All Sterile Products within expiry
Reason Lack of Assurance of Sterility .
Class II · Moderate risk Terminated
Rugby Aller-chlor
Reason Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contamination
Class II · Moderate risk Terminated
Rugby Senexon Liquid Natural Vegetable Stimulant
Reason Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contamination
Class II · Moderate risk Terminated
Rugby Diocto Syrup
Reason Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contamination
Class II · Moderate risk Terminated
Rugby Diocto Liquid
Reason Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contamination
Class II · Moderate risk Terminated
BevaDex
Reason Lack of Assurance of Sterility.
Class II · Moderate risk Terminated
Bevacizumab Prefilled 30g and 31 gram 1.25mg/0.05mL Syringes
Reason Lack of Assurance of Sterility.
Class II · Moderate risk Terminated
Fluorescein Sodium
Reason Lack of Assurance of Sterility.
Class II · Moderate risk Terminated
Sodium Bicarbonate 8.4%
Reason Lack of Assurance of Sterility.
Class II · Moderate risk Terminated
Phenylephrine2.5%/Tropicamide 1% Ophthalmic Solution
Reason Lack of Assurance of Sterility.
Class II · Moderate risk Terminated
Lidocaine Ophthalmic Gel 3.5%
Reason Lack of Assurance of Sterility.
Class II · Moderate risk Terminated
Mic 25/50/50
Reason Lack of Assurance of Sterility.
Class II · Moderate risk Terminated
L-Glutamine 100mg
Reason Lack of Assurance of Sterility.
Class II · Moderate risk Terminated
Magnesium Chloride 200mg
Reason Lack of Assurance of Sterility.
Class II · Moderate risk Terminated
Methylcobalamin 10mg
Reason Lack of Assurance of Sterility.
Class II · Moderate risk Terminated
B-Complex
Reason Lack of Assurance of Sterility.
Class II · Moderate risk Terminated
Calcium chloride 10%
Reason Lack of Assurance of Sterility.
Class II · Moderate risk Terminated
G.A.C 25/100/250mg
Reason Lack of Assurance of Sterility.
Class II · Moderate risk Terminated
Mannitol 20%
Reason Lack of Assurance of Sterility.
Class II · Moderate risk Terminated
Methylcobalamin 10mg
Reason Lack of Assurance of Sterility.
Class II · Moderate risk Terminated
PF-Glutathione 200mg/ml
Reason Lack of Assurance of Sterility.