Class I · High risk
0.9% Sodium Chloride Injection
Presence of Particulate Matter: Confirmed customer compliants of finding an insect floating in the primary container of each product.
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
Baclofen USP powder
Presence of Foreign Substance
Class II · Moderate risk
Bevacizumab 2.5 mg/0.1 mL in 3/10 mL 31 G 5/16" Syringe for intravitreal injection
Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes for intravitreal use.
Class II · Moderate risk
Bevacizumab 2 mg/0.08 mL in 3/10 mL 31 G 5/16" Syringe for intravitreal
Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes for intravitreal use.
Class II · Moderate risk
Bevacizumab 1.25 mg/0.05 mL filled to 0.06 mL in 3/10 mL 31 G…
Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes for intravitreal use.
Class II · Moderate risk
Bevacizumab 1.25 mg/0.05 mL in 3/10 mL 31 G 5/16" Syringe for…
Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes for intravitreal use.
Class II · Moderate risk
Hydrochlorothiazide Capsules
Presence of Particulate Matter
Class III · Low risk
Duloxetine Delayed-release Capsules
Presence of Foreign Tablets/Capsules: one foreign capsule identified as omeprazole 10 mg was found in the bottle
Class II · Moderate risk
Sulfamethoxazole and Trimethoprim Tablets
Presence of foreign substance -This recall has been intiated due to the presence of a polyethylene piece on the finished product.
Class II · Moderate risk
Hydrochlorothiazide Capsules
Presence of Particulate Matter.
Class II · Moderate risk
1% Lidocaine HCl Injection
Presence of Particulate Matter: particulate matter identified as iron oxide, was found embedded in the neck of glass vials.
Class II · Moderate risk
Blephamide
Presence of Particulate Matter: Due to customer complaints of small black particles, identified as part of the ointment tube cap, generated by the action of unscrewing the cap from the aluminum tube and potentially introducing the particle into the product.
Class II · Moderate risk
FML (fluorometholone ophthalmic ointment)
Presence of Particulate Matter: Due to customer complaints of small black particles, identified as part of the ointment tube cap, generated by the action of unscrewing the cap from the aluminum tube and potentially introducing the particle into the product.
Class II · Moderate risk
Refresh P.M.
Presence of Particulate Matter: Due to customer complaints of small black particles, identified as part of the ointment tube cap, generated by the action of unscrewing the cap from the aluminum tube and potentially introducing the particle into the product.
Class II · Moderate risk
Refresh Lacri-Lube
Presence of Particulate Matter: Due to customer complaints of small black particles, identified as part of the ointment tube cap, generated by the action of unscrewing the cap from the aluminum tube and potentially introducing the particle into the product.
Class II · Moderate risk
Vytorin (ezetimibe and simvastatin)
Presence of Foreign Tablet/Capsule: Vytorin 10 mg/40 mg tablets were found in bottles of Vytorin 10 mg/20 mg tablets.
Class II · Moderate risk
Midazolam HCl Syrup
Presence of Foreign Substance: customer complaint that one unit dose cup contained a small piece of cardboard contaminant.
Class III · Low risk
Methocarbamol Tablets
Presence of Foreign Substance: Presence of hair.
Class II · Moderate risk
Hydrochlorothiazide Tablet USP 25 mg
Presence of Foreign Tablet: A pharmacist found a clopidogrel tablet in the 1000-count bottle of hydrochlorothiazide 25 mg tablets.
Class I · High risk
ADRUCIL (fluorouracil injection, USP)
Presence of Particulate Matter: silcone rubber and fluorouracil crystals found floating in solution
Class I · High risk
0.9% Sodium Chloride Injection USP
Presence of Particulate Matter: Customer complaint for an insect found free floating inside a single bag for each lot recalled.
Class I · High risk
0.9% Sodium Chloride Injection USP MINI-BAG Plus Container
Presence of Particulate Matter: Customer complaint for an insect found free floating inside a single bag for each lot recalled.
Class II · Moderate risk
Sensodyne With Fluoride Repair & Protect
Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
Class II · Moderate risk
Sensodyne Extra Fresh Repair & Protect
Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
Class II · Moderate risk
Sensodyne Complete Protection
Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
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