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.
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Presence of foreign substance: identified as aluminum.
CGMP Deviations; particulates identified during visual inspection
CGMP Deviations; particulates identified during visual inspection
Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.
Presence of Foreign Substance- Black hair strand found attached to a tablet in a sealed bottle.
Presence of a foreign substance: black hair found embedded in tablet.
Presence of foreign tablets/capsules.
Presence of Foreign Tablets/Capsules: manufacturer recalled because one tadalafil 5mg tablet was found in 500 count bottle of Celecoxib 200 mg capsules
Presence of Foreign Tablets/Capsules; customer complaint found one Tadalafil 5mg tablet inside a sealed 500-count bottle of Celecoxib 200mg capsule
Presence of Particulate Matter: Glass particles were found in pellet vials.
Presence of Particulate Matter: Glass particles were found in pellet vials.
Presence of Particulate Matter: Glass particles were found in pellet vials.
Presence of Particulate Matter: Glass particles were found in pellet vials.
Presence of Particulate Matter: Glass particles were found in pellet vials.
Presence of Particulate Matter
Presence of Particulate Matter
Presence of Foreign Substance: Product complaint received for the presence of foreign material embedded resembling a metal shaving in one tablet.
Presence of foreign substance: Presence of Benzene.
Presence of foreign substance: Presence of Benzene.
Presence of Foreign Tablets/Capsules.
Presence of foreign tablets/capsules
Presence of Particulate Matter
Presence of Particulate Matter.
Presence of Foreign Tablets/Capsules
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