Class II · Moderate risk
Estradiol
Presence of Foreign substance - potential presence of metal particulate matter
Particulate & foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables.
867 FDA drug recalls with this cause, newest first.
These recalls involve visible foreign material - glass, metal, fibers, rubber or other debris - most often found in injectable or liquid products, where nothing besides the intended ingredients should be present. It also includes foreign tablets or capsules found in a bottle of a different product. In an injectable a stray particle can go straight into the bloodstream, which is why a noticeable share of these recalls are Class I.
Class II · Moderate risk
Estradiol
Presence of Foreign substance - potential presence of metal particulate matter
Class II · Moderate risk
Estradiol
Presence of Foreign substance - potential presence of metal particulate matter
Class II · Moderate risk
Estradiol
Presence of Foreign substance - potential presence of metal particulate matter
Class II · Moderate risk
Estradiol
Presence of Foreign substance - potential presence of metal particulate matter
Class II · Moderate risk
Trazodone Hydrochloride
Presence of Foreign Tablets/Capsules
Class II · Moderate risk
Furosemide Tablets
Presence of Foreign Substance
Class II · Moderate risk
Lanreotide Injection
Presence of Particulate Matter.
Class II · Moderate risk
Sterile Water for Irrigation
Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution
Class II · Moderate risk
Wegovy (semaglutide)
Presence of Particulate Matter: Hair was found in a prefilled syringe
Class II · Moderate risk
Wegovy (semaglutide)
Presence of Particulate Matter: Hair was found in a prefilled syringe
Class II · Moderate risk
Tri-Moxi+¿
Presence of particulate matter - Glass like particles.
Class II · Moderate risk
Dexamethasone Moxifloxacin Ketorolac
Presence of particulate matter - Glass like particles.
Class II · Moderate risk
Dexamethasone Moxifloxacin
Presence of particulate matter - Glass like particles.
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
Baclofen Tablets USP
Presence of Foreign Tablets/Capsules
Class II · Moderate risk
Testosterone / Triamcinolone Acetonide Pellet
CGMP Deviations: Potential presence of metal particulate matter
Class II · Moderate risk
Testosterone / Triamcinolone Acetonide Pellet
CGMP Deviations: Potential presence of metal particulate matter
Class II · Moderate risk
Testosterone / Triamcinolone Acetonide 87.5MG/17.5MCG
CGMP Deviations: Potential presence of metal particulate matter
Class II · Moderate risk
Testosterone / Triamcinolone Acetonide
CGMP Deviations: Potential presence of metal particulate matter
Class II · Moderate risk
Testosterone / Triamcinolone Acetonide 50MG/10MCG
CGMP Deviations: Potential presence of metal particulate matter
Class II · Moderate risk
Testosterone / Triamcinolone Acetonide Pellet
CGMP Deviations: Potential presence of metal particulate matter
Class II · Moderate risk
Testosterone / Triamcinolone Acetonide 25MG/5MCG
CGMP Deviations: Potential presence of metal particulate matter
Class II · Moderate risk
Testosterone / Triamcinolone Acetonide
CGMP Deviations: Potential presence of metal particulate matter
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