Reported Jul 27, 2016 · Terminated
4 mcg/mL Fentanyl Citrate and 0.125% 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?
- 4 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 100 mL in 100 mL Yellow Smiths Medical Cassette, flow stop, free-flow protection, Service Code 2T8214, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-214-48
- Lot codes and dates
40 of 40 products
Products covered by this recall # Product as published 1 Service Code 2K8130 , Lot Number 160450167M , Exp. Date 5/9/2016 2 Service Code 2K8130 , Lot Number 160460113M , Exp. Date 5/10/2016 3 Service Code 2K8130 , Lot Number 160490184M , Exp. Date 5/13/2016 4 Service Code 2K8130 , Lot Number 160540122M , Exp. Date 5/17/2016 5 Service Code 2K8130 , Lot Number 160590163M , Exp. Date 5/23/2016 6 Service Code 2K8130 , Lot Number 160610226M , Exp. Date 5/25/2016 7 Service Code 2K8130 , Lot Number 160630185M , Exp. Date 5/27/2016 8 Service Code 2K8130 , Lot Number 160670242M , Exp. Date 5/31/2016 9 Service Code 2K8130 , Lot Number 160680239M , Exp. Date 6/1/2016 10 Service Code 2K8130 , Lot Number 160730147M , Exp. Date 6/6/2016 11 Service Code 2K8130 , Lot Number 160750140M , Exp. Date 6/8/2016 12 Service Code 2K8130 , Lot Number 160770169M , Exp. Date 6/10/2016 13 Service Code 2K8130 , Lot Number 160820223M , Exp. Date 6/15/2016 14 Service Code 2K8130 , Lot Number 160840161M , Exp. Date 6/17/2016 15 Service Code 2K8130 , Lot Number 160850004M , Exp. Date 6/17/2016 16 Service Code 2K8130 , Lot Number 160960163M , Exp. Date 6/29/2016 17 Service Code 2K8214 , Lot Number 160480213M , Exp. Date 5/18/2016 18 Service Code 2K8214 , Lot Number 160490043C , Exp. Date 5/19/2016 19 Service Code 2K8214 , Lot Number 160660037M , Exp. Date 6/4/2016 20 Service Code 2K8214 , Lot Number 160680039M , Exp. Date 6/6/2016 - Amount recalled
- 936 Medical Cassettes
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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