Class II · Moderate risk
TUMS Antacid
Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
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
TUMS Antacid
Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Class II · Moderate risk
TUMS Antacid
Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Class II · Moderate risk
TUMS Antacid
Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Class II · Moderate risk
TUMS Antacid
Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Class II · Moderate risk
TUMS Antacid
Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Class II · Moderate risk
TUMS Antacid
Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Class II · Moderate risk
Oxcarbazepine Tablets 600mg
Presence of foreign substance
Class II · Moderate risk
Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg
Presence of Foreign Substance
Class I · High risk
Octreotide Acetate Injection 500 mcg/mL
Presence of Particulate Matter: Product complaint for the presence of glass particles in a syringe.
Class II · Moderate risk
Aminophylline Injection
Presence of Particulate Matter: A complaint was received for the presence of a hair in one vial.
Class III · Low risk
Tranexamic Acid Injection
Presence of Particulate Matter: Piece of metal found in a vial
Class II · Moderate risk
Acyclovir Sodium Injection
Presence of Particulate Matter: Customer complaint for a dark red, brown and black particulate floating inside vial.
Class II · Moderate risk
Ampicillin for Injection
Presence of Particulate Matter: A complaint was received for the presence of a single strand of hair in one vial.
Class II · Moderate risk
Lisinopril 10 mg tablets
Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet.
Class II · Moderate risk
Lisinopril Tablets USP
Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet.
Class II · Moderate risk
Neomycin Sulfate Tablets
CGMP Deviations: A foreign matter identified as teflon was found in the Active Pharmaceutical Ingredient (API) used in the manufacture of Neomycin Sulfate Tablets, USP 500 mg.
Class I · High risk
PROPOFOL Injectable Emulsion
Presence of particulate matter
Class II · Moderate risk
Prednisone Tablets USP
Presence of foreign tablet: 2.5 mg tablet in a 20 mg bottle of Prednisone Tablets
Class I · High risk
Propofol Injectable Emulsion
Presence of particulate matter: particulate identified as a beetle.
Class III · Low risk
buPROPion Hydrochloride Extended-Release Tablet
Presence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance found within the bottle which was determined to be activated carbon from the desiccant canister inside the bottle.
Class III · Low risk
buPROPion Hydrochloride Extended-Release Tablet
Presence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance found within the bottle which was determined to be activated carbon from the desiccant canister inside the bottle.
Class III · Low risk
Cequa (cyclosporine ophthalmic solution)
Subpotent Drug and Presence of Particulate Matter: low out-of-specification results obtained for assay and the presence of particulate matter.
Class II · Moderate risk
Janumet (sitagliptin and metformin HCl)
Presence of foreign substance: Presence of stainless steel particulates in tablets.
Class I · High risk
IDArubicin Hydrochloride Injection USP 5gm/5mL
Presence of Particulate Matter: Product was found to contain silica and iron oxide
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