Reported Jul 27, 2016 · Terminated
5 mcg/mL Fentanyl Citrate and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 250 mL in 250 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?
- 5 mcg/mL Fentanyl Citrate and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8287 (NDC 61553-287-50), 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8287 (NDC 61553-287-02), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141
- Lot codes and dates
29 of 29 products
Products covered by this recall # Product as published 1 Service Code 2H8287 , Lot Number 160390110M , Exp. Date 5/9/2016 2 Service Code 2H8287 , Lot Number 160450123M , Exp. Date 5/15/2016 3 Service Code 2H8287 , Lot Number 160470115M , Exp. Date 5/17/2016 4 Service Code 2H8287 , Lot Number 160600178M , Exp. Date 5/30/2016 5 Service Code 2H8287 , Lot Number 160750128M , Exp. Date 6/14/2016 6 Service Code 2H8287 , Lot Number 160800058M , Exp. Date 6/18/2016 7 Service Code 2H8287 , Lot Number 160820110M , Exp. Date 6/20/2016 8 Service Code 2H8287 , Lot Number 160960130M , Exp. Date 7/5/2016 9 Service Code 2H8287 , Lot Number 160970119M , Exp. Date 7/6/2016 10 Service Code 2K8287 , Lot Number 160530140M , Exp. Date 5/17/2016 11 Service Code 2K8287 , Lot Number 160630194M , Exp. Date 5/27/2016 12 Service Code 2K8287 , Lot Number 160680251M , Exp. Date 6/1/2016 13 Service Code 2K8287 , Lot Number 160760045M , Exp. Date 6/8/2016 14 Service Code 2K8287 , Lot Number 160770044M , Exp. Date 6/9/2016 15 Service Code 2K8287 , Lot Number 160770117M , Exp. Date 6/10/2016 16 Service Code 2K8287 , Lot Number 160940055M , Exp. Date 6/26/2016 17 Service Code 2K8287 , Lot Number 160960048M , Exp. Date 6/28/2016 18 Service Code 2K8811 , Lot Number 160490167M , Exp. Date 5/9/2016 19 Service Code 2K8811 , Lot Number 160530310M , Exp. Date 5/14/2016 20 Service Code 2K8811 , Lot Number 160600078M , Exp. Date 5/20/2016 - Amount recalled
- 562 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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