Reported Jul 27, 2016 · Terminated
0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, Service Code 2K8195, 100 ml in 150 ml Baxter Intravia…
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?
- 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, Service Code 2K8195, 100 ml in 150 ml Baxter Intravia Bag (NDC 61553-195-48), Service Code 2H8266, 250 ml in 250 ml Hospira LifeCare Bag NDC 61553-266-50), 100 ml in 100 ml Hospira LifeCare Bag, Service Code 2H8272(NDC 61553-272-52), 100 ml in 100 ml Yellow Smiths Medical Cassette Service Code 2K8941 (NDC 61553-941-48), 250 ml in 250 ml Baxter Intravia Bag (W/O Additive Cap) Service Code 3V8716, (NDC 61553-716-17), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141,
- Lot codes and dates
80 of 80 products
Products covered by this recall # Product as published 1 Service Code 2K8195 , Lot Number 160390084M , Exp. Date 5/9/2016 2 Service Code 2K8195 , Lot Number 160530298M , Exp. Date 5/23/2016 3 Service Code 2K8195 , Lot Number 160540203M , Exp. Date 5/24/2016 4 Service Code 2K8195 , Lot Number 160550182M , Exp. Date 5/25/2016 5 Service Code 2K8195 , Lot Number 160590153M , Exp. Date 5/29/2016 6 Service Code 2K8195 , Lot Number 160660150M , Exp. Date 6/5/2016 7 Service Code 2K8195 , Lot Number 160740115M , Exp. Date 6/12/2016 8 Service Code 2K8195 , Lot Number 160810295M , Exp. Date 6/20/2016 9 Service Code 2K8195 , Lot Number 160820217M , Exp. Date 6/21/2016 10 Service Code 2K8195 , Lot Number 160830164M , Exp. Date 6/21/2016 11 Service Code 2K8195 , Lot Number 160950236M , Exp. Date 7/4/2016 12 Service Code 2K8195 , Lot Number 160970203M , Exp. Date 7/6/2016 13 Service Code 2H8266 , Lot Number 160410177M , Exp. Date 5/11/2016 14 Service Code 2H8266 , Lot Number 160600056M , Exp. Date 5/29/2016 15 Service Code 2H8266 , Lot Number 160740185M , Exp. Date 6/13/2016 16 Service Code 2H8266 , Lot Number 160830175M , Exp. Date 6/22/2016 17 Service Code 2H8266 , Lot Number 160950218M , Exp. Date 7/4/2016 18 Service Code 2H8272 , Lot Number 160450150M , Exp. Date 5/15/2016 19 Service Code 2H8272 , Lot Number 160600070M , Exp. Date 5/29/2016 20 Service Code 2H8272 , Lot Number 160900043M , Exp. Date 6/28/2016 - Amount recalled
- 4,081 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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