Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
HYDROmorphone 10 mg in 0.9% Sodium Chloride 50 mL PCA Recalled by SSM Health Care St. Louis DBA SSM St. Clare Health Center Due to Lack of sterility assurance: Microbial growth detected during...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact SSM Health Care St. Louis DBA SSM St. Clare Health Center directly.
Affected Products
HYDROmorphone 10 mg in 0.9% Sodium Chloride 50 mL PCA, 50 mL Cartridge, Concentration: 0.2 mg/mL., This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO. --- NDC: 88883-0600-01
Quantity: N/A
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 1 state: MO
About SSM Health Care St. Louis DBA SSM St. Clare Health Center
SSM Health Care St. Louis DBA SSM St. Clare Health Center has 14 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report