Reported Jul 27, 2016 · Terminated

20 mcg/mL HYDROmorphone HCl and 0.125% 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?

  • 20 mcg/mL HYDROmorphone HCl and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Yellow Smiths Medical Cassette, Service Code 2K8947, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-947-48
Lot codes and dates

37 of 37 products

Products covered by this recall
#Product as published
1Service Code 2K8158 , Lot Number 160380113M , Exp. Date 5/8/2016
2Service Code 2K8158 , Lot Number 160410115M , Exp. Date 5/11/2016
3Service Code 2K8158 , Lot Number 160420111M , Exp. Date 5/12/2016
4Service Code 2K8158 , Lot Number 160450184M , Exp. Date 5/15/2016
5Service Code 2K8158 , Lot Number 160520106M , Exp. Date 5/21/2016
6Service Code 2K8158 , Lot Number 160530143M , Exp. Date 5/23/2016
7Service Code 2K8158 , Lot Number 160550124M , Exp. Date 5/25/2016
8Service Code 2K8158 , Lot Number 160560211M , Exp. Date 5/26/2016
9Service Code 2K8158 , Lot Number 160600195M , Exp. Date 5/30/2016
10Service Code 2K8158 , Lot Number 160620137M , Exp. Date 6/1/2016
11Service Code 2K8158 , Lot Number 160690124M , Exp. Date 6/7/2016
12Service Code 2K8158 , Lot Number 160730219M , Exp. Date 6/12/2016
13Service Code 2K8158 , Lot Number 160740084C , Exp. Date 6/14/2016
14Service Code 2K8158 , Lot Number 160770123M , Exp. Date 6/16/2016
15Service Code 2K8158 , Lot Number 160840027M , Exp. Date 6/22/2016
16Service Code 2K8158 , Lot Number 160870228M , Exp. Date 6/26/2016
17Service Code 2K8158 , Lot Number 160910212M , Exp. Date 6/30/2016
18Service Code 2K8158 , Lot Number 161080220M , Exp. Date 7/17/2016
19Service Code 2K8495 , Lot Number 160420155M , Exp. Date 5/12/2016
20Service Code 2K8495 , Lot Number 160490122M , Exp. Date 5/19/2016
Amount recalled
555 Medical Cassettes

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, 7:14 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.