Class II · Moderate risk Terminated
Sodium Chloride Injection
Reason Failed pH Specifications: Out of Specification pH Test Results were found in Sodium Chloride Injection USP 0.9% 2ml vial.
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Terminated
Sildenafil Tablets USP 100 mg
Reason Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during bottling at a 3rd party facility.
Class II · Moderate risk Terminated
Lansoprazole Delayed-Release Orally Disintegrating Tablets
Reason Failed Dissolution Specifications
Class II · Moderate risk Terminated
Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg
Reason Failed Dissolution Specifications
Class II · Moderate risk Ongoing
Zapien Productos Hand Sanitizer Gel Antibacterial
Reason cGMP deviations: Product made at the same facility where product tested was sub-potent.
Class II · Moderate risk Ongoing
Pristine gel Hand Sanitizer Gel Antibacterial Gel Moisturizing
Reason cGMP deviations: Product made at the same facility where product tested was sub-potent.
Class II · Moderate risk Ongoing
Pentosan Polysulfate
Reason Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Class II · Moderate risk Ongoing
Ll-37
Reason Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Class II · Moderate risk Ongoing
High Dose B12
Reason Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Class II · Moderate risk Ongoing
Ghk-Cu
Reason Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Class II · Moderate risk Ongoing
Thymosin Beta - 4
Reason Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Class II · Moderate risk Ongoing
Cerebrolysin
Reason Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Class II · Moderate risk Ongoing
Dsip
Reason Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Class II · Moderate risk Ongoing
B12 for Injection
Reason Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Class II · Moderate risk Ongoing
Nandrolone
Reason Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Class II · Moderate risk Ongoing
Ghrp
Reason Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Class II · Moderate risk Ongoing
Ipamorelin
Reason Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Class II · Moderate risk Ongoing
Thymosin Alpha
Reason Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Class II · Moderate risk Ongoing
Bpc-157
Reason Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Class II · Moderate risk Ongoing
Aod-9604
Reason Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Class II · Moderate risk Ongoing
Pt-141
Reason Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Class II · Moderate risk Ongoing
Fgl, 10 Mg/Ml
Reason Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Class II · Moderate risk Ongoing
Cjc-1295
Reason Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Class II · Moderate risk Terminated
Lavar 70 Gel Hand Sanitizer 70% Alcohol Content
Reason Subpotent drug
Class II · Moderate risk Terminated
UVT World Gel Hand Sanitizer 70% Alcohol Content
Reason Subpotent drug