Class II · Moderate risk
Dexamethasone Moxifloxacin
Presence of particulate matter - Glass like particles.
FDA Drug Recalls
721 recalls, newest first
Class II · Moderate risk
BD ChloraPrep" Triple Swabsticks
Lack of Assurance of Sterlity
Class II · Moderate risk
Oxycodone and Acetaminophen CII Tablets USP
Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
Class II · Moderate risk
Oxycodone and Acetaminophen CII Tablets USP
Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
Class III · Low risk
Fesoterodine Fumarate
Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
Class I · High risk
MR. 7 SUPER 700000 capsules
Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared sildenafil and tadalafil
Class III · Low risk
Glycopyrrolate Oral Solution
Failed Impurities/Degradation Specifications
Class I · High risk
ClearLife Allergy Nasal Spray
Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter.
Class I · High risk
ReBoost Nasal Spray
Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter.
Class II · Moderate risk
Noxafil Powdermix
Presence of particulate matter: potential presence of metal particulates in the product.
Class II · Moderate risk
Merck Emend
Presence of particulate matter: potential presence of metal particulates in the product.
Class II · Moderate risk
Ciclopirox Shampoo
Failed Impurity/Degradation specifications: OOS results obtained at the 18-month timepoint
Class II · Moderate risk
ORL Kids Natural Toothpaste
cGMP Deviations
Class II · Moderate risk
ORL Kids Mouthwash
cGMP Deviations
Class III · Low risk
Clindamycin Phosphate USP
Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay.
Class III · Low risk
Cisatracurium Besylate Injection USP
Subpotent product:out of specification assay results observed during long term stability testing.
Class III · Low risk
Cisatracurium Besylate Injection USP
Subpotent product:out of specification assay results observed during long term stability testing.
Class III · Low risk
Cisatracurium Besylate Injection USP
Subpotent product:out of specification assay results observed during long term stability testing.
Class II · Moderate risk
Baclofen Tablets USP
Presence of Foreign Tablets/Capsules
Class III · Low risk
Morphine Sulfate Oral Solution 100 mg / 5 mL
Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton.
Class II · Moderate risk
Duloxetine Delayed-Release Capsules
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Class II · Moderate risk
Duloxetine Delayed-Release Capsules
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Class III · Low risk
Bisoprolol Fumarate and Hydrochlorothiazide Tablets
Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe
Class II · Moderate risk
Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac…
Incorrect Product Formulation
Class III · Low risk
Nebivolol Tablets
Cross Contamination with Other Products