Class I · High risk
8.4% Sodium Bicarbonate Injection
Presence of Particulate Matter; glass particulates
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
Dimercaptopropanesulfonate Sodium
Presence of Particulate Matter: Particulates observed in vials release for dispensing.
Class I · High risk
Levoleucovorin Injection
Presence of Particulate Matter: particulate matter identified as copper salts
Class II · Moderate risk
Ezetimibe and Simvastatin Tablets 10mg/80 mg
Presence of Foreign Substance: Product complaint of black speckles observed on tablets.
Class II · Moderate risk
Lipoic Acid Injection
Presence of Particulate Matter: filmy/cloudy particulate observed in vial.
Class I · High risk
Vecuronium Bromide for Injection 20 mg* *1mg/mL when reconstituted to 20 mL Lyophilized
Presence of Particulate Matter: Foreign matter identified as glass detected in Vecuronium Bromide for Injection.
Class I · High risk
Vecuronium Bromide for Injection 10 mg*
Presence of Particulate Matter: Foreign matter identified as glass detected in Vecuronium Bromide for Injection.
Class II · Moderate risk
OZURDEX (dexamethasone intravitreal implant)
GMP Deviations: A silicone particulate was noted in Ozurdex.
Class I · High risk
Ceftriaxone for Injection USP
Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.
Class I · High risk
Ceftriaxone for Injection USP
Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.
Class I · High risk
Ceftriaxone for Injection USP
Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.
Class I · High risk
Ceftriaxone for Injection USP
Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.
Class II · Moderate risk
Estradiol Tablets
Presence of foreign tablet/capsule: A single foreign tablet was found in pharmacy dispensed bottle of 30 Estradiol 2 mg tablets.
Class II · Moderate risk
Quetiapine Tablets USP 400 mg
Presence of Foreign Substance; metal shard found in tablet
Class II · Moderate risk
Antacid Tablets
Presence of foreign substance: Product found to contain metal particles.
Class II · Moderate risk
GENTAMICIN OPTH-SOL 5ml Compare: Garamycin. 5-mL plastic dropper bottle
Presence of Particulate Matter: Crystalline particles were noticed by manufacturer at the 24 month clarity testing.
Class II · Moderate risk
Gentamicin Sulfate Ophthalmic Solution
Presence of Particulate Matter: Crystalline particles were noticed at the 24 month clarity testing.
Class III · Low risk
Fenofibrate Tablets
Presence of Foreign Tablet/Capsule: A foreign identified as Valacyclovir tablet 500 mg was co-mingled in a bottle containing Fenofibrate Tablets, USP 145 mg.
Class II · Moderate risk
Tizanidine HCl Tablets
Presence of Foreign Tablets/Capsules: Glimepiride tablet was found in a bottle of Tinzadine Hcl Tablets .
Class II · Moderate risk
Cefuroxime 10mg/mL INJ 0.5 mg
Presence of Particulate Matter: Particulate matter was reported in one lot of Cefuroxime by a physician after use of product.. FDA analysis identified the particulate as coring of the rubber stopper
Class II · Moderate risk
Lisinopril Tablets USP
Presence of Foreign Substance: Product complaint was received of metal contaminant observed in one tablet.
Class II · Moderate risk
Dymista (azelastine hydrochloride and fluticasone propionate)
Presence of foreign substance: Potential for glass in the neck area of the glass bottles.
Class II · Moderate risk
Testosterone Cypionate Injection
Presence of Particulate Matter: organic and inorganic compounds detected in vials of product.
Class II · Moderate risk
Metformin Hydrochloride Extended Release Tablets
Presence of foreign substance: One lot fo Metformin Hydrochloride Extended Release Tablets, USP, 500 mg (500 Count) contains foreign matter identified as a piece of rubber glove detected in one tablet.
Class I · High risk
Piperacillin and Tazobactam for Injection USP 3.375 grams per vial
Presence of Particulate Matter: identified as glass and silicone material
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