Class II · Moderate risk
GLIPIZIDE and METFORMIN HYDROCHLORIDE Tablets
Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.
FDA Drug Recalls
1,711 recalls, newest first
Class I · High risk
Lactated Ringers Injection
Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)
Class I · High risk
10% Dextrose Injection
Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)
Class I · High risk
5% Dextrose Injection
Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)
Class I · High risk
0.9% Sodium Chloride Injection
Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)
Class III · Low risk
Fluorescein Sodium Ophthalmic Strips USP
Failed Content Uniformity Specifications: The product may not meet finished product release specifications, including the uniformity of dosage due to a packaging degradation related to the adhesive component of the paper pouch that can impact the level of fluorescein present in the strips.
Class III · Low risk
Rose Bengal GloStrips
Failed Content Uniformity Specifications: The product may not meet finished product release specifications, including the uniformity of dosage due to a packaging degradation related to the adhesive component of the paper pouch that can impact the level of rose bengal present in the strips.
Class III · Low risk
Fluorescein Sodium Ophthalmic Strips USP
Failed Content Uniformity Specifications: The product may not meet finished product release specifications, including the uniformity of dosage due to a packaging degradation related to the adhesive component of the paper pouch that can impact the level of fluorescein present in the strips.
Class I · High risk
Gemcitabine for Injection
Presence of Particulate Matter
Class I · High risk
Gemcitabine for Injection
Presence of Particulate Matter
Class I · High risk
Gemcitabine for Injection
Presence of Particulate Matter
Class II · Moderate risk
0.9% Sodium Chloride Injection
Lack of Assurance of Sterility; increased complaints received for leaks
Class II · Moderate risk
Clinimix E 5/20 sulfite-free
Lack of Assurance of Sterility; increased complaints received for leaks
Class I · High risk
CARBOplatin Injection 450 mg/45 mL
Presence of Particulate Matter
Class I · High risk
Methotrexate Injection
Presence of Particulate Matter
Class II · Moderate risk
5% Dextrose Injection
Lack of Assurance of Sterility. Complaints were receive of missing closures and/or leaks which may compromise product sterility.
Class II · Moderate risk
0.9% Sodium Chloride Injection
Lack of Assurance of Sterility. Complaints were receive of missing closures and/or leaks which may compromise product sterility.
Class II · Moderate risk
Hydroxocobalamin 1) 1000mcg/mL
Lack of assurance of sterility
Class II · Moderate risk
Methylcobolamin 1) 6500 mcg/0.26mL
Lack of assurance of sterility
Class II · Moderate risk
Papaverine/phentolamine/prostaglandin 30/1/0.01mg/mL Injection
Lack of assurance of sterility
Class II · Moderate risk
Papaverine/phentolamine/prostaglandin 16/0.5/0.005 mg/mL Injection
Lack of assurance of sterility
Class II · Moderate risk
Papaverine/phentolamine/prostaglandin 30/1/0.025 mg/mL Injection
Lack of assurance of sterility
Class II · Moderate risk
Papaverine/phentolamine/prostaglandin 30/1/0.02 mg/mL Injection
Lack of assurance of sterility
Class II · Moderate risk
Papaverine/phentolamine/prostaglandin 30/4/0.04 mg/mL Injection
Lack of assurance of sterility
Class II · Moderate risk
Prostaglandin Rx
Lack of assurance of sterility