Class II · Moderate risk
Carisoprodol Tablets
Presence of Foreign Substance; heavy metals (chromium, titanium etc) and inactive components of the product were visually observed during routine stability testing
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 I · High risk
Soliris (eculizumab)
Presence of Particulate Matter: Failed the appearance test for the presence of visible particles.
Class II · Moderate risk
Tranexamic Acid Injection USP
Presence of Particulate Matter: Particulate matter consistent with delamination of the glass vial container.
Class II · Moderate risk
Copaxone (glatiramer acetate injection)
Presence of Particulate Matter: A foreign particle found in a pre-filled syringe was reported through a consumer complaint about a pre-filled syringe.
Class I · High risk
Marcaine (bupivacaine HCl)
Presence of Particulate Matter: Units of this lot may have visible metal particles embedded in the vial and in the solution causing the product to be discolored.
Class I · High risk
Cefepime for Injection USP and Dextrose Injection USP
Presence of Particulate Matter: The 1g Cefepime for Injection USP and Dextrose Injection USP lot has been found to contain visible organic particulate matter in a reserve sample unit.
Class II · Moderate risk
Propofol Injectable Emulsion
Presence of Particulate Matter: Visible particles embedded in the glass identified during a retain sample inspection.
Class II · Moderate risk
Ondansetron Injection
Presence of Particular Matter: Potential vendor glass issue - glass spiticules (glass strands) were identified during site inspection of the vials.
Class II · Moderate risk
Metoclopramide Injection
Presence of Particulate Matter: Potential vendor glass issue - glass spiticules (glass strands) were identified during site inspection of the vials.
Class II · Moderate risk
Prolia (denosumab)
Presence of Particulate Matter: Visible cellulose fibers were observed in a small number of prefilled syringes during a routine quality examination.
Class I · High risk
1% Lidocaine HCl Injection
Presence of Particulate Matter: Oxidized stainless steel found in vial of 1% Lidocaine Hydrochloride Injection, USP.
Class II · Moderate risk
Oxycodone and Acetaminophen Tablets
Presence of Foreign Tablets/Capsules: 20 tablets of Oxycodone/APAP 7.5/500 mg were found in a sealed 100 count bottle of Oxycodone and Acetaminophen Tablets, USP 10/650 mg lot# 705791A.
Class II · Moderate risk
Concentrated Motrin
Presence of Foreign Substance: process-related particulates which may be associated with the raw materials were observed
Class I · High risk
Aminosyn II
Presence of Particulate Matter: Confirmed customer complaint of particulate matter, identified as a human hair, visible in the injection port and primary container.
Class III · Low risk
SPIRIVA HandiHaler
Presence of Foreign Substance: This recall is being conducted due to the potential for extrinsic foreign particles in the API used to manufacture SPIRIVA Handihaler
Class I · High risk
Cubicin (daptomycin for injection)
Presence of Particulate Matter; Glass particulates observed in vials
Class II · Moderate risk
5% Lidocaine HCl and 7.5% Dextrose Injection
Presence of Particulate Matter; report of visible particulates in the glass ampule
Class II · Moderate risk
Propofol Injectable Emulsion
Presence of Particulate Matter: Visible particulate embedded in the glass vial was observed and confirmed in a sample bottle during retain sample inspection.
Class II · Moderate risk
Benztropine Mesylate Injection
Presence of particulate matter: characterized as thin colorless flakes that are visually and chemically consistent with glass delamination.
Class II · Moderate risk
Belladonna Alkaloids with Phenobarbital Tablets
Presence of Foreign Substance: black specks comprised of degraded organic material found on tablets
Class III · Low risk
Tums
Presence of Foreign Tablets/Capsules: Product labeled TUMS Ultra Assorted Berries 1000mg Chewable tables, may contain EX TUMS Assorted Berries 750mg tablets
Class II · Moderate risk
Acyclovir Tablets USP 800 mg
Presence of Particulate Matter: Product from lot KF2199, may contain tablets with pieces of nitrile rubber glove embedded within the tablets.
Class I · High risk
0.75% Bupivacaine HCl Injection
Presence of particulate matter: visible free floating and partially embedded particulate matter in the glass vials.
Class I · High risk
0.25% Bupivacaine HCl Injection
Presence of particulate matter: visible free floating and partially embedded particulate matter in the glass vials.
Class II · Moderate risk
Benztropine Mesylate Injection
Presence of particulate matter: characterized as thin colorless flakes that are visually and chemically consistent with glass delamination observed in reserve sample vials
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