Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms.
Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms.
We break every recall down into plain English — this one’s still on our list. Until our write-up is ready, the official FDA hazard and remedy below have the full, accurate details.
We’ve drafted a message you can send SSM Health Care St. Louis DBA SSM St. Clare Health Center to request your refund or repair — edit it as you like.
Subject: Recall D-0136-2018 — SSM Health Care St. Louis DBA SSM St. Clare Health Center SSM Health Care St. Louis DBA SSM St. Cla Hello, I own a SSM Health Care St. Louis DBA SSM St. Clare Health Center recalls Fentanyl 10 mcg in 0.9% Sodium Chloride 1 mL, 1 mL Vial, Concentration: 10 mcg/mL, This is a compounded injectable that is covered by recall D-0136-2018 from SSM Health Care St. Louis DBA SSM St. Clare Health Center. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
