Dr. Reddy's Laboratories QC QUALITY CHOICE, Fexofenadine HCl 60mg and Pseudoephedrine HCl recall — FDA D-0384-2022
Failed Dissolution Specifications
Browse U.S. drug recall enforcement reports from the FDA in a structured, searchable format. Review the recalled product, reason, firm, status, dates, distribution information and FDA classification when available.
10,685 detailed records are currently available in this category.
Failed Dissolution Specifications
Defective Container: The notch in the cap that fits into the nozzle of the dropper could break off and block the dropper possibly resulting in the product not dispensing.
Failed Dissolution Specifications
Labeling: Missing Label: label missing from some Semglee prefilled pens.
Failed Dissolution Specifications
CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not manufactured under Current Good Manufacturing Practices.
Failed Dissolution Specifications
Failed Dissolution Specifications
Failed Dissolution Specifications
CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not manufactured under Current Good Manufacturing Practices.
Failed Dissolution Specifications
Microbial Contamination of Non-Sterile Product
CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not manufactured under Current Good Manufacturing Practices.
Defective Delivery System
Microbial Contamination of Non-Sterile Products: presence of R. Pickettii bacteria
Lack of Assurance of Sterility
Labeling; Label mix-up and Wrong Bar Code; back label incorrectly states active ingredient as Menthol with UPC 7 14132 00071 4 instead of Peppermint Oil and Sage Oil with UPC 7 14132 00073 8
Subpotent Drug: Out of specification for assay at the 30-month stability timepoint.
Lack of Assurance of Sterility
Complaint received of foreign matter (metal) embedded in tablet.
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
A drug recall record can include the reason for recall, firm, status, distribution pattern, quantity and FDA classification. This site does not provide medical advice; it organizes public recall information and links users back to official sources.
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