Class II · Moderate risk
GE Healthcare Omnipaque
Presence of 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
GE Healthcare Omnipaque
Presence of particulate matter
Class II · Moderate risk
Children's Ibuprofen Oral Suspension
Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product.
Class III · Low risk
Pitavastatin Tablets
Presence of foreign tablets/capsules: one Pitavastatin tablet 1mg found in bottle of Pitavastatin tablets 2mg
Class II · Moderate risk
Sodium Iodide
Presence of Particulate Matter: Due to production issues
Class II · Moderate risk
Testosterone 100mg Anastrozole 4mg
Presence of Foreign substance - potential presence of metal particulate matter
Class II · Moderate risk
Testosterone 87.5mg
Presence of Foreign substance - potential presence of metal particulate matter
Class II · Moderate risk
Testosterone 200mg
Presence of Foreign substance - potential presence of metal particulate matter
Class II · Moderate risk
Testosterone 100mg
Presence of Foreign substance - potential presence of metal particulate matter
Class II · Moderate risk
Testosterone 75mg
Presence of Foreign substance - potential presence of metal particulate matter
Class II · Moderate risk
Testosterone 100mg
Presence of Foreign substance - potential presence of metal particulate matter
Class II · Moderate risk
Testosterone
Presence of Foreign substance - potential presence of metal particulate matter
Class II · Moderate risk
Testosterone
Presence of Foreign substance - potential presence of metal particulate matter
Class II · Moderate risk
Testosterone
Presence of Foreign substance - potential presence of metal particulate matter
Class II · Moderate risk
Testosterone
Presence of Foreign substance - potential presence of metal particulate matter
Class II · Moderate risk
Testosterone
Presence of Foreign substance - potential presence of metal particulate matter
Class II · Moderate risk
Testosterone
Presence of Foreign substance - potential presence of metal particulate matter
Class II · Moderate risk
Testosterone
Presence of Foreign substance - potential presence of metal particulate matter
Class II · Moderate risk
Testosterone
Presence of Foreign substance - potential presence of metal particulate matter
Class II · Moderate risk
Testosterone
Presence of Foreign substance - potential presence of metal particulate matter
Class II · Moderate risk
Testosterone
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
Estradiol
Presence of Foreign substance - potential presence of metal particulate matter
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