Reported Jul 27, 2016 · Terminated
0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Hospira LifeCare Bag Service Code…
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?
- 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Hospira LifeCare Bag Service Code 2H8194 (NDC 61553-194-52 ), 250 mL in 250 mL Cormix Bag ,Service Code 2C8192 (NDC 61553-192-17), 400 mL in 500 mL Baxter Intravia Bag, Service Code 2K8169 (NDC 61553-169-01), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141
- Lot codes and dates
146 of 146 products
Products covered by this recall # Product as published 1 Service Code 2C8192 , Lot Number 160830033M , Exp. Date 5/7/2016 2 Service Code 2H8192 , Lot Number 160380144M , Exp. Date 5/8/2016 3 Service Code 2H8192 , Lot Number 160480178M , Exp. Date 5/18/2016 4 Service Code 2H8192 , Lot Number 160610225M , Exp. Date 5/31/2016 5 Service Code 2H8192 , Lot Number 160690186M , Exp. Date 6/8/2016 6 Service Code 2H8192 , Lot Number 160730071M , Exp. Date 6/12/2016 7 Service Code 2H8192 , Lot Number 160760041M , Exp. Date 6/14/2016 8 Service Code 2H8192 , Lot Number 160820212M , Exp. Date 6/21/2016 9 Service Code 2H8192 , Lot Number 160880171M , Exp. Date 6/27/2016 10 Service Code 2H8192 , Lot Number 160940141M , Exp. Date 7/3/2016 11 Service Code 2H8192 , Lot Number 160950053M , Exp. Date 7/3/2016 12 Service Code 2H8194 , Lot Number 160410184M , Exp. Date 5/11/2016 13 Service Code 2H8194 , Lot Number 160540217M , Exp. Date 5/24/2016 14 Service Code 2H8194 , Lot Number 160550223M , Exp. Date 5/25/2016 15 Service Code 2H8194 , Lot Number 160590170M , Exp. Date 5/29/2016 16 Service Code 2H8194 , Lot Number 160630202M , Exp. Date 6/2/2016 17 Service Code 2H8194 , Lot Number 160660049M , Exp. Date 6/4/2016 18 Service Code 2H8194 , Lot Number 160740150M , Exp. Date 6/13/2016 19 Service Code 2H8194 , Lot Number 160750224M , Exp. Date 6/14/2016 20 Service Code 2H8194 , Lot Number 160760187M , Exp. Date 6/15/2016 - Amount recalled
- 8,581 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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