Class III · Low risk
Simvastatin Tablets
Presence of foreign substance: metallic razor blade was found in one bottle.
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
Fosphenytoin Sodium Injection
Presence of particulate matter
Class II · Moderate risk
0.25% Acetic Acid Irrigation USP
Presence of Particulate Matter: identified as polyethylene, which is consistent with the material used to manufacture the contain cap
Class III · Low risk
Auryxia (ferric citrate)
Presence of Foreign Substance: Reports have been received of damaged StripPax packets containing silica gel desiccant potentially allowing the silica gel granules to make contact with Auryxia tablets in the bottle.
Class I · High risk
Pantoprazole Sodium for Injection
Presence of Particulate Matter: One vial from a lot of Pantoprazole Sodium for Injection (40 mg) contained a piece of glass
Class II · Moderate risk
Paroxetine Tablets USP
Presence of Foreign Tablets/Capsules: Risperidone Tablets were found in bottle of Paroxetine Tablets
Class II · Moderate risk
Pravastatin Sodium USP
Presence of foreign tablets/capsules: This product lot is being recalled due to a pharmacy complaint where one Duloxetine Delayed Release Capsule, 30mg was found in a Pravastatin Sodium Tablets USP, 40mg bottle.
Class I · High risk
Nexterone (amiodarone HCl)
Presence of Particulate Matter:Particulate identified as polyethylene, the primary constituent of the film and ports used to manufacture the bag in which product is packaged
Class II · Moderate risk
Paroxetine Tablets
Presence of Foreign Tablets/Capsules.
Class II · Moderate risk
Levetiracetam Oral Solution
Presence of foreign substance (screw)
Class II · Moderate risk
Procrit (epoetin alfa)
Presence of particulate matter: glass flakes identified as lamellae observed during a routine quality inspection.
Class II · Moderate risk
Fosphenytoin Sodium Injection
Presence of Particulate Matter
Class I · High risk
Vancomycin Hydrochloride for Injection
Presence of Particulate Matter: glass particulate found in vial
Class II · Moderate risk
Paroxetine tablets USP
Presence of Foreign tablets/capsules: risperidone Tablets were found in bottle of paroxetine Tablets
Class II · Moderate risk
Amoxicillin and Clavulanate Potassium for Oral Suspension
Presence of Foreign Substance: customer complaint of blue foreign material identified as a portion of a nitrile glove was discovered in product.
Class II · Moderate risk
Procrit Epoetin Alfa 40
Presence of particulate matter: Visible glass flakes identified as lamellae in some drug product vials.
Class II · Moderate risk
0.9% Sodium Chloride Injection
Presence of Particulate Matter; stainless steel
Class II · Moderate risk
Hydromorphone Hydrochloride Injection
Presence of Particulate Matter: Silicone oil
Class II · Moderate risk
Hydromorphone Hydrochloride Injection
Presence of Particulate Matter: Silicone oil
Class II · Moderate risk
Hydromorphone Hydrochloride Injection
Presence of Particulate Matter: Silicone oil
Class II · Moderate risk
parodontax WHITENING
Presence of Foreign Substance: possibility of the presence of metal in the product.
Class II · Moderate risk
Ibuprofen Tablets
Presence of foreign tablets/capsules: Ibuprofen Tablets USP, 600 mg bottles were found to contain some Ibuprofen Tablets USP 800 mg.
Class II · Moderate risk
Magnesium Citrate Saline Laxative Cherry Flavored
Presence of foreign substance: glass particle
Class I · High risk
BRILINTA (ticagrelor)
Presence of Foriegn Tablets/Capsules: customer complaint that an 8-count professional sample bottle labeled as BRILINTA 90 mg tablets contained 5 ZURAMPIC 200 mg tablets, in addition to the expected 8 BRILINTA tablets.
Class III · Low risk
Mefenamic Acid Capsules
Presence of foreign substance: The recall was initiated due to black particles being observed while performing routine post-release stability testing on Mefenamic acid capsules
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