Reported Jul 27, 2016 · Terminated
3.5 mcg/mL Fentanyl Citrate and 0.0625%Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 125 mL in 150 mL…
Pharmedium Services, LLC
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: Pharmedium Services, LLC · 150 N Field Dr Ste 350 · Lake Forest, IL · 60045-2506
Is this the product you have?
- 3.5 mcg/mL Fentanyl Citrate and 0.0625%Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 125 mL in 150 mL Baxter Intravia Bag, Service Code 2K8470, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-470-30
- Lot codes and dates
9 of 9 products
Products covered by this recall # Product as published 1 Lot Number 160390336M , Exp. Date 5/9/2016 2 Lot Number 160530318M , Exp. Date 5/23/2016 3 Lot Number 160600347M , Exp. Date 5/30/2016 4 Lot Number 160750243M , Exp. Date 6/14/2016 5 Lot Number 160760164M , Exp. Date 6/14/2016 6 Lot Number 160830228M , Exp. Date 6/22/2016 7 Lot Number 160890224M , Exp. Date 6/28/2016 8 Lot Number 160960242M , Exp. Date 7/5/2016 9 Lot Number 160970140M , Exp. Date 7/6/2016 - Amount recalled
- 1,015 bags
This recall covers 75 products
The agency filed one notice per product. You are reading one of them; the other 74 are below.
62 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
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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