Class II · Moderate risk
Nystatin Topical Powder
Presence of Foreign Substance: potential presence of plastic particles.
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 III · Low risk
Amlodipine Besylate Tablet
PRESENCE OF FOREIGN TABLETS/CAPSULES: A 2.5 mg Amlodipine Besylate tablet was found co-mingled with 10 mg Amlodipine Besylate tablets in a bottle labeled as Amlodipine Besylate 10 mg.
Class III · Low risk
Acyclovir Tablets
Presence of Foreign Substance: human hair melded into tablet.
Class I · High risk
Infant 25% DEXTROSE Injection
Presence of Particulate Matter: human hair found within an internal sample syringe.
Class II · Moderate risk
Kalbitor (ecallantide)
Presence of Particulate Matter: Glass
Class II · Moderate risk
Testosterone Cypionate Injection
Presence of Particulate Matter
Class II · Moderate risk
ATENOLOL Tablets
Presence of Foreign Tablets/Capsules: Customer complaint that a bottle of atenolol 50 mg Tablets USP contained a paroxetine 20 mg tablet.
Class II · Moderate risk
Sensodyne Repair & Protect Whitening
Presence of Foreign Substance; low concentration of an additional flavoring ingredient, Patchouli oil resulting in complaints of off flavor/scent
Class II · Moderate risk
ATENOLOL Tablets
Presence of Foreign Tablets/Capsules: Customer complaint that a bottle of atenolol 50 mg Tablets USP contained a paroxetine 20 mg tablet.
Class II · Moderate risk
Aspirin Chewable Tablets
Presence of Foreign Substance: foreign material found in the bulk inventory.
Class II · Moderate risk
HealthA2Z CHEWABLE Aspirin
cGMP deviations - presence of rubber particles found loose in the bulk product.
Class I · High risk
Ibuprofen Lysine Injection
Presence of Particulate Matter
Class I · High risk
Vancomycin HCl 750 mg added to 5% Dextrose 250 mL For IV Use Only
Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter.
Class I · High risk
Vancomycin HCl 750 mg added to 250 mL 0.9% Sodium Chloride For IV Use Only
Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter.
Class I · High risk
Vancomycin HCl 1.5 gram added to 5% Dextrose 500 mL Total…
Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter.
Class I · High risk
Vancomycin HCl 1.5 g added to 0.9% Sodium Chloride 250 mL Bag For IV Use Only Rx Only
Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter.
Class I · High risk
Vancomycin HCl 1.25 g added to 0.9% Sodium Chloride 250 mL Bag For IV Use Only
Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter.
Class I · High risk
Vancomycin HCl 1 g added to 0.9% Sodium Chloride 250 mL Bag For IV Use Only
Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter.
Class I · High risk
Vancomycin HCl 1.25 g added to 5% Dextrose 250 mL Bag For IV Use Only
Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter.
Class II · Moderate risk
Mirtazapine Tablets
Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablets commingled
Class I · High risk
Vancomycin Hydrochloride for Injection
Presence of Particulate Matter: A hair was found stuck to the stopper of inside a single vial. The hair came in contact with the reconstituted drug product.
Class II · Moderate risk
Mirtazapine Tablets
Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablet in bottle
Class II · Moderate risk
glipiZIDE Extended-Release Tablets
Presence of Foreign Tablets/Capsules; bottles of Glipizide 5 mg tablets may contain Glipizide 10 mg tablets
Class II · Moderate risk
Alfuzosin Hydrochloride Extended-release Tablets
Presence of Foreign Substance: consumer complaint for foreign matter embedded in the tablet identified as a broken piece of wire rope from the manufacturing equipment.
Class III · Low risk
Pentasa (mesalamine)
Presence of Foreign Tablets/Capsules; 500 mg capsules were found in bottles labeled to contain 250 mg capsules
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