Reported Jul 27, 2016 · Terminated
2.5 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 200 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?
- 2.5 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 200 mL in 250 mL Baxter Intravia Bag, Service Code K8255 (NDC 61553-255-37), 200 ml in 250 ml Baxter Intravia Bag ; Service Code 2K8464 (NDC 61553-464-61), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141
- Lot codes and dates
29 of 29 products
Products covered by this recall # Product as published 1 Service Code 2H8255 , Lot Number 160550161M , Exp. Date 5/11/2016 2 Service Code 2H8255 , Lot Number 160620170M , Exp. Date 5/18/2016 3 Service Code 2H8255 , Lot Number 160760132M , Exp. Date 6/1/2016 4 Service Code 2H8255 , Lot Number 160830148M , Exp. Date 6/8/2016 5 Service Code 2H8255 , Lot Number 160900158M , Exp. Date 6/15/2016 6 Service Code 2H8255 , Lot Number 160970139M , Exp. Date 6/22/2016 7 Service Code 2K8255 , Lot Number 160490046C , Exp. Date 5/13/2016 8 Service Code 2K8255 , Lot Number 160620032C , Exp. Date 5/26/2016 9 Service Code 2K8255 , Lot Number 160770046C , Exp. Date 6/10/2016 10 Service Code 2K8464 , Lot Number 160420154M , Exp. Date 5/6/2016 11 Service Code 2K8464 , Lot Number 160530249M , Exp. Date 5/17/2016 12 Service Code 2K8464 , Lot Number 160540207M , Exp. Date 5/18/2016 13 Service Code 2K8464 , Lot Number 160660045M , Exp. Date 5/29/2016 14 Service Code 2K8464 , Lot Number 160730092M , Exp. Date 6/6/2016 15 Service Code 2K8464 , Lot Number 160840137M , Exp. Date 6/17/2016 16 Service Code 2K8464 , Lot Number 160910145M , Exp. Date 6/24/2016 17 Service Code 2T8255 , Lot Number 160480271M , Exp. Date 5/9/2016 18 Service Code 2T8255 , Lot Number 160530302M , Exp. Date 5/14/2016 19 Service Code 2T8255 , Lot Number 160600047C , Exp. Date 5/21/2016 20 Service Code 2T8255 , Lot Number 160610032C , Exp. Date 5/22/2016 - Amount recalled
- 2,006 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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