SSM Health Care recalls phenylephrine HCl syringes (NDC 60652-0104-1) with potential sterility issues. These IV drugs are for hospital/office use only and not for resale. Affected lots expire through July 2024.
Lack of Assurance of Sterility: Firm did not perform process validation.
SSM Health Care is recalling phenylephrine HCl syringes used in hospitals and clinics due to a lack of sterility assurance. This means the syringes could be contaminated, posing a risk of infection if used in medical procedures.
The syringes were compounded without proper process validation, meaning they may not be sterile. If used in medical procedures, this could lead to infections in patients.
Healthcare providers using these syringes in hospitals or clinics are most at risk. Patients receiving IV treatments with these syringes could be exposed to infection.
Check for the NDC code 60652-0104-1 on the syringe label. The lot numbers range from 20230912-847E0C to 20240109-837CB8 with expiration dates through July 2024.
Look for the NDC code 60652-0104-1 and lot numbers listed in the recall notice.
The recall states there is a lack of sterility assurance, so these syringes should not be used until the recall is resolved.
The recall does not specify a remedy, so contact SSM Health Care directly for guidance.
Check for the NDC code 60652-0104-1 and lot numbers from 20230912-847E0C to 20240109-837CB8 with expiration dates through July 2024.
We’ve drafted a message you can send SSM Health Care to request your refund or repair — edit it as you like.
Subject: Recall D-0435-2024 — SSM Health Care SSM Health Care Hello, I own a SSM Health Care that is covered by recall D-0435-2024 from SSM Health Care. 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.
