Class II · Moderate risk
Auryxia (ferric citrate)
CGMP Deviations
FDA Drug Recalls
708 recalls · Class II, newest first
Class II · Moderate risk
Vumerity (diroximel fumarate)
Failed dissolution specifications: out-of-specification test results observed during the buffer stage dissolution testing.
Class II · Moderate risk
Docetaxel Injection USP 160 mg/8mL
CGMP Deviations
Class II · Moderate risk
Imatinib Mesylate Tablets 400 mg
CGMP Deviations
Class II · Moderate risk
Imatinib Mesylate Tablets 100 mg
CGMP Deviations
Class II · Moderate risk
Azacitidine for Injection 100 mg/vial
CGMP Deviations
Class II · Moderate risk
Azacitidine for Injection 100 mg/vial
CGMP Deviations
Class II · Moderate risk
Busulfan Injection 60 mg/10 mL
CGMP Deviations
Class II · Moderate risk
Sodium Chloride Injection
Failed pH Specifications: Out of Specification pH Test Results were found in Sodium Chloride Injection USP 0.9% 2ml vial.
Class II · Moderate risk
Sildenafil Tablets USP 100 mg
Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during bottling at a 3rd party facility.
Class II · Moderate risk
Lansoprazole Delayed-Release Orally Disintegrating Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg
Failed Dissolution Specifications
Class II · Moderate risk
Zapien Productos Hand Sanitizer Gel Antibacterial
cGMP deviations: Product made at the same facility where product tested was sub-potent.
Class II · Moderate risk
Pristine gel Hand Sanitizer Gel Antibacterial Gel Moisturizing
cGMP deviations: Product made at the same facility where product tested was sub-potent.
Class II · Moderate risk
Pentosan Polysulfate
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
Ll-37
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
High Dose B12
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
Ghk-Cu
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
Thymosin Beta - 4
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
Cerebrolysin
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
Dsip
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
B12 for Injection
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
Nandrolone
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
Ghrp
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
Ipamorelin
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.