Class II · Moderate risk
Paroxetine tablets USP
Presence of Foreign tablets/capsules: risperidone Tablets were found in bottle of paroxetine Tablets
FDA Drug Recalls
621 recalls · Class II, newest first
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 II · Moderate risk
Nystatin Topical Powder
Presence of Foreign Substance: potential presence of plastic particles.
Class II · Moderate risk
Kalbitor (ecallantide)
Presence of Particulate Matter: Glass
Class II · Moderate risk
Testosterone Cypionate Injection
Presence of Particulate Matter
Class II · Moderate risk
ATENOLOL Tablets
Presence of Foreign Tablets/Capsules: Customer complaint that a bottle of atenolol 50 mg Tablets USP contained a paroxetine 20 mg tablet.
Class II · Moderate risk
Sensodyne Repair & Protect Whitening
Presence of Foreign Substance; low concentration of an additional flavoring ingredient, Patchouli oil resulting in complaints of off flavor/scent
Class II · Moderate risk
ATENOLOL Tablets
Presence of Foreign Tablets/Capsules: Customer complaint that a bottle of atenolol 50 mg Tablets USP contained a paroxetine 20 mg tablet.
Class II · Moderate risk
Aspirin Chewable Tablets
Presence of Foreign Substance: foreign material found in the bulk inventory.
Class II · Moderate risk
HealthA2Z CHEWABLE Aspirin
cGMP deviations - presence of rubber particles found loose in the bulk product.
Class II · Moderate risk
Mirtazapine Tablets
Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablets commingled
Class II · Moderate risk
Mirtazapine Tablets
Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablet in bottle
Class II · Moderate risk
glipiZIDE Extended-Release Tablets
Presence of Foreign Tablets/Capsules; bottles of Glipizide 5 mg tablets may contain Glipizide 10 mg tablets
Class II · Moderate risk
Alfuzosin Hydrochloride Extended-release Tablets
Presence of Foreign Substance: consumer complaint for foreign matter embedded in the tablet identified as a broken piece of wire rope from the manufacturing equipment.
Class II · Moderate risk
Metformin Hydrochloride Tablets
Presence of Foreign Tablets/Capsules; report of Amlodipine Tablets found in 1000 count bottles of Metformin Hydrochloride Tablets USP
Class II · Moderate risk
DIPYRIDAMOLE Tablets USP
Presence of foreign tablets/capsules: 50 mg Persantine tablets were found in a 75 mg Persantine 100-count bottle and 50 mg Persantine tablet was found in a 100 count bottle of 75 mg Dipyridamole.
Class II · Moderate risk
Persantine
Presence of foreign tablets/capsules: 50 mg Persantine tablets were found in a 75 mg Persantine 100-count bottle and 50 mg Persantine tablet was found in a 100 count bottle of 75 mg Dipyridamole.