Class I · High risk
Methotrexate Injection
Presence of Particulate Matter
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
0.9% Sodium Chloride Injection
Presence of Particulate Matter: Confirmed finding of human hair floating in IV solution.
Class II · Moderate risk
Droperidol injection
Presence of particulate.
Class II · Moderate risk
Promethazine Dm Syrup
Presence of Foriegn Substance: Plastic cap closure particulates may be present in the product.
Class II · Moderate risk
Mafenide Acetate
Presence of Foreign Substance; oxidized steel, organic material and shredded polypropylene
Class I · High risk
PHENYLephrine HCl
Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair).
Class I · High risk
PHENYLephrine HCl
Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair).
Class I · High risk
PHENYLephrine HCl
Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair).
Class I · High risk
Fentanyl Citrate
Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair).
Class I · High risk
Morphine Sulfate
Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair).
Class I · High risk
Bupivacaine HCl 0.0625%
Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair).
Class I · High risk
PHENYLephrine HCl
Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair).
Class I · High risk
PHENYLephrine HCl
Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair).
Class II · Moderate risk
Ketorolac Tromethamine Ophthalmic Solution
Presence of Particulate Matter: lot is not meeting the specification limit for number of particles present in the solution.
Class I · High risk
0.9% Sodium Chloride Injection
Presence of Particulate Matter; Hospira has identified the particulate as a human hair, sealed in the bag at the additive port area.
Class II · Moderate risk
Children's Loratadine Syrup
Presence of Foreign Substance: Presence of blue plastic floating in loratadine syrup.
Class II · Moderate risk
Propofol Injectable Emulsion
Presence of Particulate Matter: The firm received a complaint of an embedded particulate in the neck of one vial composed primarily of iron.
Class II · Moderate risk
Hydroxocobalamin Injection Solution 1 mg/mL Inj.
Presence of Particulate Matter; preservative may not have dissolved completely or precipitated out of product
Class I · High risk
0.9% Sodium Chloride Injection USP
Presence of Particulate Matter: Confirmed customer complaints received for the presence of blue plastic, identified as fragments of the frangible from the vial adapter.
Class II · Moderate risk
HydrALAZINE Hydrochloride Tablets
Presence of Foreign Substance: Par Pharmaceutical, Inc. is recalling one lot of HydrALAZINE Hydrochloride tablets due to the presence of small aluminum particles.
Class I · High risk
1% LIDOCAINE HCl Injection
Presence of particulate matter: A returned customer sample was evaluated and found to have human hair attached to a pinched area of the stopper.
Class III · Low risk
Truvada (200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate)
Presence of Foreign Substance: Truvada was found to contain small red silicone rubber particulates.
Class III · Low risk
BENZONATATE Capsules
Presence of Foreign Capsules/Tablets: Benzonatate 100 mg co-mingled with benzonatate 200 mg capsules.
Class II · Moderate risk
CREON (pancrelipase)
Presence of Foreign Tablets/Capsules; Presence of co-mingled LipaCreon 13000.
Class II · Moderate risk
TOPIRAMATE Tablets 200 mg
Presence of Foreign Tablets: Presence of topiramate 100 mg tablets comingled with 200 mg tablets.
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