Class I · High risk
LACTATED RINGER'S 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 II · Moderate risk
Alprazolam Tablets
Presence of Foreign Substance
Class III · Low risk
Atorvastatin Calcium Tablets
Presence of Foreign Tablets/Capsules: a single tablet of Pravastatin 40 mg found in bottle of Atorvastatin Calcium 40 mg.
Class III · Low risk
Methylphenidate Hydrochloride Oral Solution 5mg per 5mL
Presence of Foreign Substance; Fiber particles.
Class II · Moderate risk
Children's Ibuprofen Oral Suspension USP
Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
Class II · Moderate risk
Children's Ibuprofen Oral Suspension USP
Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
Class II · Moderate risk
Children's Ibuprofen Oral Suspension USP
Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
Class II · Moderate risk
Ibuprofen Oral Suspension USP
Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
Class II · Moderate risk
Ibuprofen Oral Suspension USP
Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
Class II · Moderate risk
Estradiol tablets
Presence of Foreign Tablets/Capsules: Estradiol 1 mg was found in a 100 count bottle of Estradiol 0.5 mg Tablets.
Class III · Low risk
Benazepril HCl Tablets
Presence of Foreign Tablet/Capsule; Promethazine HCl tablet found in the Benazepril HCl bottle
Class II · Moderate risk
Lidocaine Hydroclhoride Jelly USP
cGMP Deviations: firm reported finding metal particulate matter in the filling room near the tube feeder during the filling operation of the product. No particulates were identified in the product, but rather were identified on the filling line.
Class II · Moderate risk
Lisinopril/HCTZ 20mg/12.5mg Tablet
Presence of Foreign Tablets/Capsules: This is a spin-off recall of D-1581-2019 due to a product complaint where one of Lupin's Fenofibrate 145mg was observed in the 500 s count product bottle.
Class II · Moderate risk
Lisinopril and Hydrochlorothiazide Tablets USP
Presence of Foreign Tablets/Capsules: Product complaint received of one Fenofibrate tablet 145mg observed in 500 s count product bottle.
Class III · Low risk
Methylergonovine Maleate USP 0.2 mg Tablets a) 12 count
Presence of Foreign Tablet/Capsule; one Promethazine tablet was found in a bottle of Methylergonovine Maleate tablets
Class II · Moderate risk
Lisinopril and Hydrochlorothiazide Tablets USP
Presence of Foreign Substance; Product complaints received related to brownish/blackish stains on the tablets and brownish/blackish powder observed inside the bottles.
Class I · High risk
Fluorouracil Injection
Presence of Particulate Matter; glass particulates
Class II · Moderate risk
Cefdinir for Oral Suspension USP
Complaint received of metal piece identified in the product bottle prior to the reconstitution.
Class I · High risk
Mycophenolate Mofetil for Injection
Presence of Particulate Matter; glass fragment observed in one vial of reconstituted product
Class III · Low risk
Carvedilol Tablets
Presence of Foreign Tablets/Capsules: Customer complaint for a small, solid, light yellow substance, identified as a fragmented tablet of another drug product, found mixed with tablets in a bottle of Carvedilol tablets 3.125mg.
Class I · High risk
Lidocaine HCl Injection
Presence of Particulate Matter: One vial was found to contain a hair.
Class II · Moderate risk
Pravastatin Sodium Tablets USP
Presence Of Foreign Tablet: in a bottle of Pravastatin Sodium Tablets 20 mg.
Class II · Moderate risk
Testosterone Cypionate Injection
Presence of Particulate Matter.
Class II · Moderate risk
Testosterone Cypionate Injection
Presence of Particulate Matter.
Class II · Moderate risk
Testosterone Cypionate Injection
Presence of Particulate Matter.
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