Class III · Low risk
Simvastatin Tablets
Presence of foreign substance: metallic razor blade was found in one bottle.
FDA Drug Recalls
49 recalls, newest first
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