Class III · Low risk
Olanzapine
Subpotent drug
FDA Drug Recalls
14,806 recalls, newest first
Class III · Low risk
Olanzapine
Subpotent drug
Class II · Moderate risk
0.9% Sodium Chloride Injection
Lack of Sterility Assurance: The product has the potential to leak at the administrative port.
Class II · Moderate risk
C-Topical 4% CII
Labeling: Label mix-up; bottles were incorrectly labeled as 10 mL instead of correctly labeled as 4 mL
Class III · Low risk
Fexofenadine Hydrochloride Tablets
Failed Impurities/Degradation Specifications: the manufacturer, recalled product due to slightly above specification results for a Related Compound during routine stability testing
Class III · Low risk
Cartia XT (diltiazem HCl extended-release capsules, USP)
Presence of Foreign Substance; fine residue or dust identified as aluminum may be on exterior of the capsule shell
Class III · Low risk
Promethazine Vc With Codeine Syrup
Failed Impurities/Degradation Specifications: A stability lot was out of specification for a known impurity at the 8 month Controlled Room Temperature stability time-point.
Class II · Moderate risk
GLIPIZIDE and METFORMIN HYDROCHLORIDE Tablets
Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.
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