Class II · Moderate risk
Sensodyne Extra Fresh Complete Protection
Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
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
biotene PBF Toothpaste
Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
Class II · Moderate risk
biotene Gentle Formula FLUORIDE TOOTHPASTE GENTLE MINT
Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
Class II · Moderate risk
biotene Gentle Formula FLUORIDE TOOTHPASTE Fresh Mint Original
Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
Class II · Moderate risk
biotene Gentle Mint Gel
Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
Class III · Low risk
Cvs Sugar Free Black Cherry Cough Drops
Presence of Foreign Tablets/Capsules: Presence of comingled Sugar Free Honey Lemon cough drops.
Class II · Moderate risk
NEXIUM¿ (esomeprazole magnesium)
Presence of Foreign Tablets/Capsules: Confimed customer compliant by a retail pharmacist that an unopened bottle labeled as NEXIUM¿ capsules contained 60 SEROQUEL¿ XR tablets.
Class I · High risk
Adrucil (fluorouracil injection, USP)
Presence of Particulate Matter: Black particulate matter was identified as aggregate of silicone rubber pieces from a filler diaphragm and fluorouracil crystals.
Class I · High risk
Cytarabine Injection 100 mg/5 mL
Presence of Particulate Matter
Class I · High risk
Bupivacaine Hydrochloride Inj.
Presence of Particulate Matter: Presence of free-floating and embedded iron oxide particles.
Class I · High risk
EPINEPHrine HCl 4 mg added to 250 mL 0.9% Sodium Chloride Injection USP
Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP which were subsequently recalled by the manufacturer due to the presence of particulate matter.
Class I · High risk
HEPARIN Sodium Injection USP 25
Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP which were subsequently recalled by the manufacturer due to the presence of particulate matter.
Class I · High risk
EPINEPHrine HCl 16 mg added to 250 mL 0.9% Sodium Chloride Injection USP
Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP which were subsequently recalled by the manufacturer due to the presence of particulate matter.
Class I · High risk
HEPARIN Sodium Injection USP
Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP which were subsequently recalled by the manufacturer due to the presence of particulate matter.
Class I · High risk
EPINEPHrine HCl 1 mg added to 250 mL 0.9% Sodium Chloride Injection USP
Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP which were subsequently recalled by the manufacturer due to the presence of particulate matter.
Class I · High risk
oxyTOCIN 15 Units added to 250 mL 5% Dextrose Injection USP
Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP which were subsequently recalled by the manufacturer due to the presence of particulate matter.
Class III · Low risk
Cartia XT (diltiazem HCl extended-release capsules, USP)
Presence of Foreign Substance; fine residue or dust identified as aluminum may be on exterior of the capsule shell
Class I · High risk
Lactated Ringers Injection
Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)
Class I · High risk
10% Dextrose Injection
Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)
Class I · High risk
5% Dextrose Injection
Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)
Class I · High risk
0.9% Sodium Chloride Injection
Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)
Class I · High risk
Gemcitabine for Injection
Presence of Particulate Matter
Class I · High risk
Gemcitabine for Injection
Presence of Particulate Matter
Class I · High risk
Gemcitabine for Injection
Presence of Particulate Matter
Class I · High risk
CARBOplatin Injection 450 mg/45 mL
Presence of Particulate Matter
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