SSM Health Care St. Louis DBA SSM St. Clare Phenylephrine HCl, 1000 mcg/10 mL, 10 mL Total recall — FDA D-0435-2024
Lack of Assurance of Sterility: Firm did not perform process validation.
Overview of recall records associated with SSM Health Care St. Louis DBA SSM St. Clare Health Center, including dates, categories and classifications where available.
Classification mix: Class II: 3.
Lack of Assurance of Sterility: Firm did not perform process validation.
Lack of Assurance of Sterility: Firm did not perform process validation.
CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or…
This page summarizes recall records in which the official source identifies SSM Health Care St. Louis DBA SSM St. Clare Health Center 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.