Reported Jul 27, 2016 · Terminated

20 mcg/mL HYDROmorphone HCl and 0.06% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 55 mL in 60 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 0.06% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 55 mL in 60 mL Monoject Syringe, Service Code 2T6620, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-620-12
Lot codes and dates

10 of 10 products

Products covered by this recall
#Product as published
1Service Code 2K8157 , Lot Number 160420116M , Exp. Date 5/12/2016
2Service Code 2K8157 , Lot Number 160540135M , Exp. Date 5/24/2016
3Service Code 2K8157 , Lot Number 160630121M , Exp. Date 6/2/2016
4Service Code 2K8157 , Lot Number 160730218M , Exp. Date 6/12/2016
5Service Code 2K8157 , Lot Number 160760126M , Exp. Date 6/14/2016
6Service Code 2K8157 , Lot Number 160770152M , Exp. Date 6/16/2016
7Service Code 2K8157 , Lot Number 160810169M , Exp. Date 6/20/2016
8Service Code 2K8157 , Lot Number 160840206M , Exp. Date 6/23/2016
9Service Code 2K8157 , Lot Number 160940210M , Exp. Date 7/3/2016
10Service Code 2T6620 , Lot Number 160900133M , Exp. Date 5/6/2016
Amount recalled
435 Monoject Syringes

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, 6:24 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.