Reported Jul 27, 2016 · Terminated

20 mcg/mL HYDROmorphone HCl and 0.1% 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 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 ml in 100 mL Yellow Smiths Medical Cassette, flow stop free-flow protection, Service Code 2T8216, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-216-96
Lot codes and dates

9 of 9 products

Products covered by this recall
#Product as published
1Lot Number 160600315M , Exp. Date 5/7/2016
2Lot Number 160670256M , Exp. Date 5/14/2016
3Lot Number 160730057M , Exp. Date 5/20/2016
4Lot Number 160740144M , Exp. Date 5/20/2016
5Lot Number 160800152M , Exp. Date 5/27/2016
6Lot Number 160900142M , Exp. Date 6/5/2016
7Lot Number 160910123M , Exp. Date 6/6/2016
8Lot Number 160940037M , Exp. Date 6/9/2016
9Lot Number 161080048M , Exp. Date 6/24/2016
Amount recalled
212 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, 5:52 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.