Leiter's Compounding Cyclopentolate HCl 1% - Tropicamide 1% - PHENYLephrine HCl 2.5% in recall — FDA D-0013-2017
Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
Overview of recall records associated with Leiter's Compounding, including dates, categories and classifications where available.
Classification mix: Class II: 8.
Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
This page summarizes recall records in which the official source identifies Leiter's Compounding 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.