Class II · Moderate risk
Daytrana (methylphenidate transdermal system)
Defective Delivery System: Out of specification for mechanical peel and shear.
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
Daytrana (methylphenidate transdermal system)
Defective Delivery System: Out of specification for mechanical peel and shear.
Class II · Moderate risk
Daytrana (methylphenidate transdermal system)
Defective Delivery System: Out of specification for mechanical peel and shear.
Class II · Moderate risk
Daytrana (methylphenidate transdermal system)
Defective Delivery System: Out of specification for mechanical peel and shear.
Class II · Moderate risk
Carbidopa and Levodopa Tablets
Product Mix-Up: A foreign tablet was found in bottle.
Class II · Moderate risk
Sunstar GUM Toothpaste 3 g tubes
cGMP Deviation
Class II · Moderate risk
Elelyso (taliglucerase alfa)
Lack of Assurance of Sterility--Reports of loose metal ferrule crimps on vials for injection. The entire cap either lifted or dislodged while attempting to flip off the orange color plastic button.
Class II · Moderate risk
Morphine Sulfate
Lack Of Processing Controls
Class II · Moderate risk
Vancomycin 900MG in 100ML 0.9% NACL Injectable
Lack Of Processing Controls
Class II · Moderate risk
Ertapenem in 100ML 0.9% NACL 1GM Injectable
Lack Of Processing Controls
Class II · Moderate risk
Daptomycin
Lack Of Processing Controls
Class II · Moderate risk
Morphine Sulfate
Lack Of Processing Controls
Class II · Moderate risk
Acetylcysteine Ophthalmic 10% Solution
Lack Of Processing Controls
Class II · Moderate risk
Mesalamine Delayed-Release Tablets
Failed Dissolution Specifications: Low out of specification dissolution result observed during stability testing.
Class II · Moderate risk
Desoximetasone Topical Spray
Failed Impurities/Degradation Specification; high out of specification results observed
Class II · Moderate risk
Memantine Hydrochloride Extended Release Capsules
Failed Dissolution Specifications: Low out of specification results observed in dissolution test at six-month long-term stability study.
Class II · Moderate risk
Amoxicillin and Clavulanate Potassium Tablets
Presence of Foreign Substance: Customer complaint of a foreign substance identified as nylon cable tie
Class II · Moderate risk
Desmopressin Acetate Tablets
GMP Deviations: Product bottle may be absent of desiccant.
Class II · Moderate risk
Desmopressin Acetate Tablets
GMP Deviations: Product bottle may be absent of desiccant.
Class II · Moderate risk
Caduet (amlodipine besylate/atorvastatin calcium)
Defective Container: products potentially could have been packaged in defective bottles, with a notched rim, that could cause inadequate foil sealing resulting in lack of moisture protection.
Class II · Moderate risk
Caduet (amlodipine besylate/atorvastatin calcium)
Defective Container: products potentially could have been packaged in defective bottles, with a notched rim, that could cause inadequate foil sealing resulting in lack of moisture protection.
Class II · Moderate risk
Major Extra Strength Acetaminophen Tablets
Presence of Foreign Tablets/Capsules: Complaint involving one Women's Prenatal dietary supplement tablet commingled in a bottle of Extra Strength Acetaminophen 500 mg contents 1000 count bottle.
Class II · Moderate risk
Leader Extra Strength Acetaminophen Tablets
Presence of Foreign Tablets/Capsules: Complaint involving one Women's Prenatal dietary supplement tablet commingled in a bottle of Extra Strength Acetaminophen 500 mg contents 1000 count bottle.
Class II · Moderate risk
Fentanyl Citrate Inj.
Defective Container: confirmed customer reports for vials with loose metal overseal crimp defects, which may result in lack of assurance of sterility.
Class II · Moderate risk
New! Rompe Pecho MAX Multi Symptoms
Microbial Contamination of Non-Sterile Products