Reported Jul 26, 2023 · Terminated
ROcuronium Bromide 50 mg/5 mL ( 10 mg/mL), 5mL Syringe, RX Only, Advanced Compounding Solutions, 4 Constitution Way Ste…
New England Life Care, Inc. dba Advanced Compounding Solutions
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: New England Life Care, Inc. dba Advanced Compounding Solutions · 4 Constitution Way Ste L · Woburn, MA · 01801-1042
Is this the product you have?
ROcuronium Bromide 50 mg/5 mL ( 10 mg/mL)5mL SyringeRX OnlyAdvanced Compounding Solutions4 Constitution Way Ste L WoburnMA 01801-1042
- NDC71546-090-05
- Lot codes and dates
Lot # 20230524-530F73Exp 21OCT2023
- Amount recalled
- 500 Syringes
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
Why it was recalled
CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
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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