Class II · Moderate risk
Esomeprazole Magnesium for Delayed-Release Oral Suspension 40mg
Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
Class II drug recalls - moderate risk
Class II means the product may cause temporary or medically reversible harm, and serious harm is unlikely. It is by far the largest recall class - most potency, dissolution and labeling problems land here.
14,543 recalls, newest first.
Class II · Moderate risk
Esomeprazole Magnesium for Delayed-Release Oral Suspension 20mg
Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
Class II · Moderate risk
Esomeprazole Magnesium for Delayed-Release Oral Suspension 10mg
Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
Class II · Moderate risk
Ascend Laboratories
Failed Impurity/Degradation Specifications
Class II · Moderate risk
Ascend Laboratories
Failed Impurity/Degradation Specifications
Class II · Moderate risk
Dexamethasone - Moxifloxacin PF Injection
Lack of assurance of sterility: 13 vials were discovered to have faulty crimps.
Class II · Moderate risk
Class II · Moderate risk
Azacitidine for Injection 100 mg/vial For Subcutaneous and…
cGMP deviations: Vials may not be sealed correctly affecting sterility.
Class II · Moderate risk
Sensorcaine-MPF
Subpotent Drug: Low out-of-specification assay results for the epinephrine component.
Class II · Moderate risk
Hydroxyzine Hydrochloride Oral Solution
Failed Impurities/Degradation Specification: OOS for the following - unknown degradant/impurity, 4-chorobenzophenone, and for total impurities.
Class II · Moderate risk
Auryxia (ferric citrate)
CGMP Deviations
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.