Class II · Moderate risk Ongoing
Freskaro refresh & revitalize Magnesium Citrate Saline Laxative…
Reason MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria.
FDA Drug Recalls
14,450 recalls · Class II, newest first
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 II · Moderate risk Ongoing
Sertraline Tablets
Reason CGMP Deviations: Inadequate line clearance which may result in a potential comingling of product.
Class II · Moderate risk Ongoing
Nystatin 150 Mu
Reason Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Class II · Moderate risk Ongoing
Nystatin 2 Bu
Reason Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Class II · Moderate risk Ongoing
Nystatin 500 Mu
Reason Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Class II · Moderate risk Ongoing
Nystatin 5bu
Reason Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Class II · Moderate risk Terminated
Liothyronine Sodium Tablets
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Completed
ROPivacaine HCl 0.2% PF in Sodium Chloride 1
Reason STAQ Pharma Inc. received consumer complaints related to leaking bags and other potential bag concerns. Upon investigation, they determine the source of the issue was with the bag manufacturer who released bags Lot # 134142-001A which had failed internal QC tests for leaks.
Class II · Moderate risk Terminated
Thiamine HCl/Pyridoxine HCl 20 mg/mL /100mg/ml Injection Solution
Reason Presence of Particulate Matter.
Class II · Moderate risk Terminated
B-Complex
Reason Presence of Particulate Matter.
Class II · Moderate risk Terminated
Penicillamine Tablets USP 250 mg
Reason Failed Dissolution Specifications
Class II · Moderate risk Completed
ceFAZolin sodium in Sterile Water for injection
Reason Lack of assurance of sterility.
Class II · Moderate risk Completed
Ondansetron Injection
Reason Failed pH Specifications
Class II · Moderate risk Ongoing
KinderMed INFANTS' PAIN & FEVER Acetaminophen
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Ongoing
KinderMed KIDS' PAIN & FEVER Acetaminophen
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Terminated
PAROXETINE tablets
Reason Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out of specification results for the excipient Amadori Glucose adduct of Paroxetine
Class II · Moderate risk Terminated
PAROXETINE tablets
Reason Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out of specification results for the excipient Amadori Glucose adduct of Paroxetine
Class II · Moderate risk Terminated
PAROXETINE tablets
Reason Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out of specification results for the excipient Amadori Glucose adduct of Paroxetine