Reported Jul 27, 2016 · Terminated

2 mcg/mL Fentanyl Citrate and 0.25% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 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 0.25% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Hospira LifeCare Bag, Service Code 2H8103 (NDC 61553-103-52), 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8444 (NDC 61553-444-61), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141 ,
Lot codes and dates

8 of 8 products

Products covered by this recall
#Product as published
1Service Code 2H8103 , Lot Number 160450153M , Exp. Date 5/11/2016
2Service Code 2K8444 , Lot Number 160490047C , Exp. Date 5/13/2016
3Service Code 2K8444 , Lot Number 160540031C , Exp. Date 5/18/2016
4Service Code 2K8444 , Lot Number 160610039C , Exp. Date 5/25/2016
5Service Code 2K8444 , Lot Number 160730032C , Exp. Date 6/6/2016
6Service Code 2K8444 , Lot Number 160760038C , Exp. Date 6/9/2016
7Service Code 2K8444 , Lot Number 160800049C , Exp. Date 6/13/2016
8Service Code 2K8444 , Lot Number 160960053C , Exp. Date 6/29/2016
Amount recalled
95 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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Mar 6, 2018 · Data as of Sep 19, 4:55 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.