Phenylephrine HCl Syringes Recalled for Sterility Assurance Failure
SSM Health Care is recalling 11,798 compounded Phenylephrine HCl intravenous syringes distributed to Missouri hospitals and medical offices due to lack of process validation for sterility assurance.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of an intravenous injectable with lack of sterility assurance, which poses a potential risk of serious infection. No illnesses, injuries, or hospitalizations have been reported, making this a theoretical risk-of-harm scenario that meets criteria for High severity.
Plain-English summary
SSM Health Care St. Louis is recalling approximately 11,798 compounded intravenous Phenylephrine HCl syringes (1000 mcg/10 mL) that were distributed to hospitals and medical offices in Missouri. The recall affects seven specific lot numbers manufactured between September 2023 and January 2024.
The firm initiated this recall because it did not perform adequate process validation to ensure sterility assurance. Intravenous medications must be sterile, and the failure to validate the sterilization process creates a potential risk of contamination.
Affected lot numbers are: 20240109-837CB8 (expires 07-Jul-2024), 20231219-08D09D (expires 16-Jun-2024), 20231121-20F8BB (expires 19-May-2024), 20231115-2FF64D (expires 13-May-2024), 20231101-09C52B (expires 29-Apr-2024), 20231010-3D0B35 (expires 07-Apr-2024), and 20230912-847E0C (expires 10-Mar-2024).
Healthcare providers and patients who received doses from these lot numbers should contact SSM Health Care St. Louis. No illnesses have been reported associated with this recall.
The recalled product
- 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
- Manufacturer
- SSM Health Care St. Louis DBA SSM St. Clare Health Center
- Category
- Drug — Injectable / Compounded
- Hazard
- sterility-failure
- contamination-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (14)
- 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.
Distribution
Distributed in 1 state:
- MO
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