Reported Jul 27, 2016 · Terminated
2 mcg/mL Fentanyl Citrate and 0.25% 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 0.25% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Hospira LifeCare Bag, Service Code 2H8103 (NDC 61553-103-52), 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8444 (NDC 61553-444-61), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141 ,
- Lot codes and dates
8 of 8 products
Products covered by this recall # Product as published 1 Service Code 2H8103 , Lot Number 160450153M , Exp. Date 5/11/2016 2 Service Code 2K8444 , Lot Number 160490047C , Exp. Date 5/13/2016 3 Service Code 2K8444 , Lot Number 160540031C , Exp. Date 5/18/2016 4 Service Code 2K8444 , Lot Number 160610039C , Exp. Date 5/25/2016 5 Service Code 2K8444 , Lot Number 160730032C , Exp. Date 6/6/2016 6 Service Code 2K8444 , Lot Number 160760038C , Exp. Date 6/9/2016 7 Service Code 2K8444 , Lot Number 160800049C , Exp. Date 6/13/2016 8 Service Code 2K8444 , Lot Number 160960053C , Exp. Date 6/29/2016 - Amount recalled
- 95 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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