ECI Pharmaceuticals, LLC
FDA issued a warning letter to ECI Pharmaceuticals, LLC (Fort Lauderdale, FL) regarding drug registration and listing violations for two esterified estrogens and methyltestosterone products (NDC 51293-639 and NDC 51293-640). The firm submitted electronic listing files identifying 'conjugated estrogens' as the active ingredient, which does not match the 'esterified estrogens' stated on the product labeling — two distinct, non-equivalent ingredients. This constitutes a violation of FD&C Act sections 510(j) and 301(p), and renders the products misbranded under section 502(o). FDA previously notified the firm of these deficiencies in October and December 2021, resulting in removal from the Online NDC Directory, and now requires written corrective action within 15 working days.
Required actions (2)
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.
Failure to adequately address this matter may result in legal action including, without limitation, seizure, and injunction.
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