Reported Jul 27, 2016 · Terminated
2 mcg/mL Fentanyl Citrate and 0.08% 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?
- 2 mcg/mL Fentanyl Citrate and 0.08% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Hospira LifeCare Bag, Service Code 2H8296 (NDC 61553-296-52), 125 mL in 150 mL Baxter Intravia Bag, Service Code 2K8296 (NDC 61553-296-22), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141 ,
- Lot codes and dates
27 of 27 products
Products covered by this recall # Product as published 1 Service Code 2H8296 , Lot Number 160420192M , Exp. Date 5/8/2016 2 Service Code 2H8296 , Lot Number 160450199M , Exp. Date 5/11/2016 3 Service Code 2H8296 , Lot Number 160490146M , Exp. Date 5/15/2016 4 Service Code 2H8296 , Lot Number 160590180M , Exp. Date 5/25/2016 5 Service Code 2H8296 , Lot Number 160660231M , Exp. Date 6/1/2016 6 Service Code 2H8296 , Lot Number 160700136M , Exp. Date 6/5/2016 7 Service Code 2H8296 , Lot Number 160770233M , Exp. Date 6/12/2016 8 Service Code 2H8296 , Lot Number 160820140M , Exp. Date 6/17/2016 9 Service Code 2H8296 , Lot Number 160880282M , Exp. Date 6/23/2016 10 Service Code 2H8296 , Lot Number 160910131M , Exp. Date 6/26/2016 11 Service Code 2H8296 , Lot Number 160970117M , Exp. Date 7/1/2016 12 Service Code 2H8296 , Lot Number 161080157M , Exp. Date 7/13/2016 13 Service Code 2K8296 , Lot Number 160420191M , Exp. Date 5/12/2016 14 Service Code 2K8296 , Lot Number 160480230M , Exp. Date 5/18/2016 15 Service Code 2K8296 , Lot Number 160540227M , Exp. Date 5/24/2016 16 Service Code 2K8296 , Lot Number 160610205M , Exp. Date 5/31/2016 17 Service Code 2K8296 , Lot Number 160670249M , Exp. Date 6/6/2016 18 Service Code 2K8296 , Lot Number 160830181M , Exp. Date 6/22/2016 19 Service Code 2K8296 , Lot Number 160840213M , Exp. Date 6/23/2016 20 Service Code 2T6296 , Lot Number 160450196M , Exp. Date 5/15/2016 - Amount recalled
- 1,476 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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