Reported Jul 27, 2016 · Terminated
3 mcg/mL Fentanyl Citrate and 0.0625% 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?
- 3 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Hospira LifeCare Bag, Service Code 2H8180 (NDC 61553-180-52), 250 mL in 250 mL Hospira LifeCare Bag Service Code 2H8262 (NDC 61553-262-50), 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8180 (NDC 61553-180-02), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141
- Lot codes and dates
21 of 21 products
Products covered by this recall # Product as published 1 Service Code 2H8180 , Lot Number 160450152M , Exp. Date 5/11/2016 2 Service Code 2H8180 , Lot Number 160830040M , Exp. Date 6/17/2016 3 Service Code 2H8262 , Lot Number 160380102M , Exp. Date 5/8/2016 4 Service Code 2H8262 , Lot Number 160750131M , Exp. Date 6/14/2016 5 Service Code 2H8262 , Lot Number 161080121M , Exp. Date 7/17/2016 6 Service Code 2K8180 , Lot Number 160460038C , Exp. Date 5/10/2016 7 Service Code 2K8180 , Lot Number 160480026C , Exp. Date 5/12/2016 8 Service Code 2K8180 , Lot Number 160550022C , Exp. Date 5/19/2016 9 Service Code 2K8180 , Lot Number 160620021C , Exp. Date 5/26/2016 10 Service Code 2K8180 , Lot Number 160680038C , Exp. Date 6/1/2016 11 Service Code 2K8180 , Lot Number 160760022C , Exp. Date 6/9/2016 12 Service Code 2K8180 , Lot Number 160770042C , Exp. Date 6/10/2016 13 Service Code 2K8180 , Lot Number 160830034C , Exp. Date 6/16/2016 14 Service Code 2K8180 , Lot Number 160900094C , Exp. Date 6/23/2016 15 Service Code 2K8180 , Lot Number 160940033C , Exp. Date 6/27/2016 16 Service Code 2K8180 , Lot Number 160970035C , Exp. Date 6/30/2016 17 Service Code 2K8905 , Lot Number 160810187M , Exp. Date 6/11/2016 18 Service Code 2K8905 , Lot Number 160890186M , Exp. Date 6/18/2016 19 Service Code 2K8975 , Lot Number 160550132M , Exp. Date 5/15/2016 20 Service Code 2K8975 , Lot Number 160610229M , Exp. Date 5/22/2016 - Amount recalled
- 345 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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