ECI Pharmaceuticals, LLC Warning Letter Details

Summary

ECI Pharmaceuticals, LLC was cited for failure to properly register and list two drug products containing esterified estrogens and methyltestosterone (NDCs 51293-639 and 51293-640) in violation of Section 510(j) of the FD&C Act and 21 CFR 207. The company submitted incorrect active ingredient names in its electronic Drug Registration and Listing System (eDRLS) filing, listing "conjugated estrogens" instead of the actual "esterified estrogens" found on the product labeling—these are different and non-equivalent ingredients. This deficiency was not corrected despite two prior FDA notification letters in October and December 2021, resulting in the products' removal from FDA's Online NDC Directory and rendering them misbranded under Section 502(o) of the FD&C Act.