Reported Jul 27, 2016 · Terminated
2 mcg/mL Fentanyl Citrate and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 130 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?
- 2 mcg/mL Fentanyl Citrate and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 130 mL in 150 mL Baxter Intravia Bag, Service Code, 2K9226 (NDC 61553-226-98), 200 mL in 250 mL Baxter Intravia Bag, Service Code 2K9294 (NDC 61553-0294-92), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141
- Lot codes and dates
13 of 13 products
Products covered by this recall # Product as published 1 Service Code 2K9226 , Lot Number 160450145M , Exp. Date 5/9/2016 2 Service Code 2K9226 , Lot Number 160530166M , Exp. Date 5/17/2016 3 Service Code 2K9226 , Lot Number 160560080M , Exp. Date 5/19/2016 4 Service Code 2K9226 , Lot Number 160670164M , Exp. Date 5/31/2016 5 Service Code 2K9226 , Lot Number 160730130M , Exp. Date 6/6/2016 6 Service Code 2K9226 , Lot Number 160770032M , Exp. Date 6/10/2016 7 Service Code 2K9226 , Lot Number 160810035M , Exp. Date 6/13/2016 8 Service Code 2K9226 , Lot Number 160820135M , Exp. Date 6/15/2016 9 Service Code 2K9226 , Lot Number 160870152M , Exp. Date 6/20/2016 10 Service Code 2K9226 , Lot Number 160890036M , Exp. Date 6/22/2016 11 Service Code 2K9226 , Lot Number 160950040M , Exp. Date 6/27/2016 12 Service Code 2K9294 , Lot Number 160400210M , Exp. Date 5/10/2016 13 Service Code 2K9294 , Lot Number 160700164M , Exp. Date 6/9/2016 - Amount recalled
- 950 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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