Geritrex GRx HiCort 25 recall — FDA D-0392-2016
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Overview of recall records associated with Geritrex Corp, including dates, categories and classifications where available.
Classification mix: Class II: 4, Class III: 1.
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
CGMP Deviation: Poor container closure of the bulk storage container
This page summarizes recall records in which the official source identifies Geritrex Corp as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.