Class II · Moderate risk
fentaNYL 2000 mcg/100 mL
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
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
fentaNYL 400 mcg/200 mL
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Class II · Moderate risk
fentaNYL 200 mcg/100 mL
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Class II · Moderate risk
fentaNYL 250 mcg/5 mL
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Class II · Moderate risk
fentaNYL 200 mcg/100 mL
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Class II · Moderate risk
fentaNYL 2750 mcg/55 mL
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Class II · Moderate risk
fentaNYL 200 mcg/100 mL
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Class II · Moderate risk
fentaNYL 100 mcg/2 mL
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Class II · Moderate risk
fentaNYL 1000 mcg/100 mL
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Class II · Moderate risk
fentaNYL 400 mcg/200 mL
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Class II · Moderate risk
fentaNYL 2500 mcg/250 mL
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Class II · Moderate risk
fentaNYL 500 mcg/250 mL
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Class II · Moderate risk
fentaNYL 1500 mcg/30 mL
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Class II · Moderate risk
fentaNYL 200 mcg/100 mL
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Class II · Moderate risk
fentaNYL 500 mcg/250 mL
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Class II · Moderate risk
fentaNYL 200 mcg/100 mL
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Class II · Moderate risk
fentaNYL 500 mcg/250 mL
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Class II · Moderate risk
fentaNYL 500 mcg/250 mL
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Class II · Moderate risk
Lidocaine HCl Injection
Presence of Foreign Substance: Foreign material found inside the vial.
Class II · Moderate risk
Valganciclovir Hydrochloride for Oral Solution
Presence of foreign substance: Brown/black particles found during stability testing.
Class II · Moderate risk
Hydrocodone Bitartrate and Homatropine Methlybromide Oral Solution 5 mg/1.5 mg per 5 mL
Presence of Foreign Substance: Black particles were found in the lots during retain sample inspection
Class III · Low risk
Cefdinir for Oral Suspension USP
Presence of Foreign substance: identified as a dead ant.
Class III · Low risk
Cefdinir for Oral Suspension USP
Presence of Foreign substance: identified as a dead ant.
Class III · Low risk
Cephalexin for Oral Suspension USP
Presence of Foreign substance: identified as a dead ant.
Class I · High risk
0.9% Sodium Chloride Injection
Presence of Particulate Matter.
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