Reported Jul 27, 2016 · Terminated

5 mcg/mL HYDROmorphone HCl 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 HYDROmorphone HCl and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 ml Hospira LifeCare Bag, Service Code 2H8477 (NDC 61553-477-50), 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8477 (NDC 61553-477-61), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141
Lot codes and dates

19 of 19 products

Products covered by this recall
#Product as published
1Service Code 2H8477 , Lot Number 160400137M , Exp. Date 5/10/2016
2Service Code 2H8477 , Lot Number 160450131M , Exp. Date 5/15/2016
3Service Code 2H8477 , Lot Number 160470138M , Exp. Date 5/17/2016
4Service Code 2H8477 , Lot Number 160480132M , Exp. Date 5/18/2016
5Service Code 2H8477 , Lot Number 160550129M , Exp. Date 5/25/2016
6Service Code 2H8477 , Lot Number 160610059M , Exp. Date 5/30/2016
7Service Code 2H8477 , Lot Number 160620029M , Exp. Date 5/31/2016
8Service Code 2H8477 , Lot Number 160680044M , Exp. Date 6/6/2016
9Service Code 2H8477 , Lot Number 160750038M , Exp. Date 6/13/2016
10Service Code 2H8477 , Lot Number 160760128M , Exp. Date 6/14/2016
11Service Code 2H8477 , Lot Number 160820118M , Exp. Date 6/21/2016
12Service Code 2H8477 , Lot Number 160830037M , Exp. Date 6/22/2016
13Service Code 2H8477 , Lot Number 160890044M , Exp. Date 6/27/2016
14Service Code 2H8477 , Lot Number 160900040M , Exp. Date 6/28/2016
15Service Code 2H8477 , Lot Number 160960037M , Exp. Date 7/4/2016
16Service Code 2H8477 , Lot Number 160970136M , Exp. Date 7/6/2016
17Service Code 2K8477 , Lot Number 160520174M , Exp. Date 5/22/2016
18Service Code 2K8477 , Lot Number 160890053M , Exp. Date 6/27/2016
19Service Code 2K8477 , Lot Number 160940139M , Exp. Date 7/3/2016
Amount recalled
445 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.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new produce recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

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, 7:11 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.