Class II · Moderate risk
Baclofen/Bupivacaine 2
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
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.
14,535 recalls, newest first.
Class II · Moderate risk
Baclofen 1
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Class II · Moderate risk
Baclofen 500 mcg/mL Injectable
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Class II · Moderate risk
Avastin 1.25 mg/0.05 mL Injectable
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Class II · Moderate risk
Methotrexate 25mg/mL Injectable
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Class II · Moderate risk
CLENZIderm M.D. Acne Therapeutic System Normal to Oily Skin kit
cGMP Deviations; during the production process, CLENZIderm M.D. Daily Foam Cleanser was filled into some bottles labeled as CLENZIderm M.D. Pore Therapy
Class II · Moderate risk
DOBUTamine in 5% Dextrose Injection
Lack of Assurance of Sterility: Confirmed report of leaking in the primary container.
Class II · Moderate risk
Levoxyl (levothyroxine sodium)
Subpotent Drug: The products were below specification for potency at the expiry stability point.
Class II · Moderate risk
Levoxyl (levothyroxine sodium)
Subpotent Drug: The products were below specification for potency at the expiry stability point.
Class II · Moderate risk
Levoxyl (levothyroxine sodium)
Subpotent Drug: The products were below specification for potency at the expiry stability point.
Class II · Moderate risk
Levoxyl (levothyroxine sodium)
Subpotent Drug: The products were below specification for potency at the expiry stability point.
Class II · Moderate risk
Levoxyl (levothyroxine sodium)
Subpotent Drug: The products were below specification for potency at the expiry stability point.
Class II · Moderate risk
Levoxyl (levothyroxine sodium)
Subpotent Drug: The products were below specification for potency at the expiry stability point.
Class II · Moderate risk
Levoxyl (levothyroxine sodium)
Subpotent Drug: The products were below specification for potency at the expiry stability point.
Class II · Moderate risk
Levoxyl (levothyroxine sodium)
Subpotent Drug: The products were below specification for potency at the expiry stability point.
Class II · Moderate risk
Levoxyl (levothyroxine sodium)
Subpotent Drug: The products were below specification for potency at the expiry stability point.
Class II · Moderate risk
Levoxyl (levothyroxine sodium)
Subpotent Drug: The products were below specification for potency at the expiry stability point.
Class II · Moderate risk
Levoxyl (levothyroxine sodium)
Subpotent Drug: The products were below specification for potency at the expiry stability point.
Class II · Moderate risk
Cornea Coat
Marketed without an Approved NDA/ANDA.
Class II · Moderate risk
Ropinirole hydrochloride tablets
Labeling: Label Error on Declared Strength- Unopened bottles of Ropinirole USP 3 mg tablets was found to be incorrectly labeled as Ropinirole USP 4 mg tablets..
Class II · Moderate risk
Pyridoxine 100mg/ml Inj MDV
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Class II · Moderate risk
Meperidine 100mg/ml MDV
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Class II · Moderate risk
Lidocaine 2% Inj MDV
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Class II · Moderate risk
M.I.C.+B12 Inj MDV: 3x50ml
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Class II · Moderate risk
Glutathione 200mg/ml Inj SDV: 3x50ml 14 day expiration
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.