Reported Jan 3, 2018 · Terminated
HYDROmorphone 10 mg in 0.9% Sodium Chloride 50 mL PCA, 50 mL Cartridge, Concentration
SSM Health Care St. Louis dba SSM St. Clare Health Center
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: SSM Health Care St. Louis DBA SSM St. Clare Health Center · 1015 Bowles Ave · Fenton, MO · 63026-2394
Is this the product you have?
HYDROmorphone 10 mg in 0.9% Sodium Chloride 50 mL PCA, 50 mL Cartridge, Concentration
3 of 3 products
| # | Product as published |
|---|---|
| 1 | 2 mg/mL., This is a compounded injectable drug |
| 2 | Rx only |
| 3 | Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO. --- NDC: 88883-0600-01 |
- Lot codes and dates
- Lot
- exp
170615-0049/13/2017170720-00910/18/2017
- Amount recalled
- N/A
This recall covers 10 products
The agency filed one notice per product. You are reading one of them; the other 9 are below.
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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