Fexofenadine HCl Tablets
Failed Impurities/Degradation Specifications
Class II means the product may cause temporary or medically reversible harm, and serious harm is unlikely. It is by far the largest recall class - most potency, dissolution and labeling problems land here.
14,543 recalls, newest first.
Failed Impurities/Degradation Specifications
Failed Stability Specifications.
Labeling: Not Elsewhere Classified; product is labeled as "Non-Corn Source" however the product is from a corn source.
Marketed Without An Approved NDA/ANDA: product contains Selective Androgen Receptor Modulators (SARMs)
Failed Impurities/Degradation Specifications
Failed Impurities/Degradation Specifications
Failed Impurities/Degradation Specifications
Failed Impurities/Degradation Specifications
Failed Impurities/Degradation Specifications
Failed Impurities/Degradation Specifications
Failed Impurities/Degradation Specifications
Failed Impurities/Degradation Specifications
Failed Impurities/Degradation Specifications
Failed Impurities/Degradation Specifications
Failed Impurities/Degradation Specifications
Lack of Assurance of Sterility.
Microbial Contamination of Non-Sterile Products: contamination with Burkholderia and Pseudomonas.
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility