Class II · Moderate risk
Ascend Laboratories
Failed Impurity/Degradation Specifications
FDA drug recalls in 2020
Every FDA drug recall initiated in 2020, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
930 recalls, newest first.
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 III · Low risk
Succinylcholine Chloride PF Inj. 200 mg/10 mL
Labeling: Incorrect or Missing lot and/or expiration date: The lot number and BUD were printed in the incorrect position on the product label making it illegible.
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 I · High risk
TraZODONE Hydrochloride 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
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.