Phenylephrine HCl recall
FDA recall D-0435-2024 · initiated Feb 29, 2024
SSM Health Care St. Louis DBA SSM St. Clare Health Center recalled Phenylephrine HCl in Feb 2024 — an FDA Class II recall (D-0435-2024) because Lack of Assurance of Sterility: Firm did not perform process validation.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Lack of Assurance of Sterility: Firm did not perform process validation.
Sterility could not be assured
The maker could not guarantee the product was sterile. That matters most for injections and eye products, where a contaminated dose reaches past the body's defences.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 11,798 syringes
Details
- Product
- Phenylephrine HCl, 1000 mcg/10 mL, 10 mL Total Volume per syringe, Intravenous, Rx Only, Hospital/Office Use Only, This is a Compounded Drug - Not for Resale, SSM Health Care Corporation Outsourcing Facility, 1015 Bowles Ave, Fenton, MO 63026-2394. NDC: 60652-0104-1
- Recalling company
- SSM Health Care St. Louis DBA SSM St. Clare Health Center
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- MO
- Initiated
- Feb 29, 2024
- FDA report date
- Apr 10, 2024
Frequently asked
- Was Phenylephrine HCl recalled?
- SSM Health Care St. Louis DBA SSM St. Clare Health Center recalled Phenylephrine HCl in Feb 2024 — an FDA Class II recall (D-0435-2024) because Lack of Assurance of Sterility: Firm did not perform process validation. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Phenylephrine HCl recalled?
- Per the FDA enforcement record, the reason for recall D-0435-2024 was: Lack of Assurance of Sterility: Firm did not perform process validation.
- Is a recalled Phenylephrine HCl dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Phenylephrine HCl are affected?
- Distributed: MO. The recall covers these lots — Lot #s: 20240109-837CB8, Exp. 07-Jul-2024; 20231219-08D09D, Exp. 16-Jun-2024; 20231121-20F8BB, Exp. 19-May-2024; 20231115-2FF64D, Exp. 13-May-2024; 20231101-09C52B, Exp. 29-Apr-2024; 20231010-3D0B35, Exp. 07-Apr-2024; 20230912-847E0C, Exp. 10-Mar-2024.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0435-2024.