Class I · High risk Ongoing
FentaNYL citrate PF
Reason Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
FDA Drug Recalls
17,898 recalls, newest first
Class II · Moderate risk Ongoing
DELFLEX Peritoneal Dialysis Solution in Biofine container 1.5% Dextrose
Reason Lack of Sterility Assurance
Class II · Moderate risk Ongoing
Quality Choice No Drip Severe Congestion Nasal Pump Mist
Reason CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.
Class II · Moderate risk Ongoing
Quality Choice No Drip Extra Moisturizing Nasal Pump Mist…
Reason CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.
Class II · Moderate risk Ongoing
Premier Value Tussin Cough DM
Reason CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.
Class II · Moderate risk Ongoing
Nasal Spray Original No Drip Oxymetazoline HCl Nasal Solution
Reason CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.
Class II · Moderate risk Terminated
Divalproex Sodium Extended-release Tablets
Reason Failed dissolution specifications
Class I · High risk Ongoing
Robitussin Honey CF Max Nighttime Adult
Reason Microbial Contamination of Non-Sterile Products
Class I · High risk Ongoing
Robitussin Honey CF Max Non-Drowsy Adult
Reason Microbial Contamination of Non-Sterile Products
Class III · Low risk Ongoing
Benzonatate Capsules
Reason Superpotent drug: Assay results were slightly above specification at the time zero point.
Class I · High risk Ongoing
Bleomycin for Injection
Reason Presence of particulate matter: glass
Class I · High risk Completed
Americaine
Reason Chemical Contamination: presence of benzene
Class I · High risk Ongoing
Atropine Sulfate Injection
Reason Presence of Particulate Matter; identified as glass
Class I · High risk Ongoing
8.4 % Sodium Bicarbonate Injection
Reason Presence of Particulate Matter; identified as glass
Class I · High risk Ongoing
4.2% Sodium Bicarbonate Injection
Reason Presence of Particulate Matter; identified as glass
Class II · Moderate risk Ongoing
Freskaro refresh & revitalize Magnesium Citrate Saline Laxative…
Reason MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria.
Class II · Moderate risk Ongoing
Freskaro refresh & revitalize Magnesium Citrate Saline Laxative…
Reason MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria.
Class II · Moderate risk Ongoing
CVS Health Magnesium Citrate Saline Laxative Oral Solution DYE…
Reason MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria.
Class II · Moderate risk Ongoing
Walgreens Dye-Free Magnesium Citrate Saline Laxative/Oral Solution
Reason MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria.
Class II · Moderate risk Ongoing
Good Neighbor Pharmacy
Reason MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria.
Class II · Moderate risk Terminated
Desloratadine Tablets USP 5mg a) 100 count
Reason CGMP Deviations: N-Nitroso Desloratadine impurity result exceeded the acceptable intake limit.
Class II · Moderate risk Terminated
Tacrolimus Capsules
Reason Presence of Foreign Tablets/Capsules: One 0.5 mg Tacrolimus capsule found in a bottle of 1 mg Tacrolimus capsules.
Class II · Moderate risk Ongoing
Selenium Sulfide 2.25% Shampoo
Reason CGMP Deviations: Stability data does not support expiry date.
Class III · Low risk Terminated
Anoro Ellipta
Reason Failed Release Testing: Coarse Particle Mass for umeclidinium Out of Specification
Class II · Moderate risk Ongoing
Sertraline Tablets
Reason CGMP Deviations: Inadequate line clearance which may result in a potential comingling of product.