Reported Jul 27, 2016 · Terminated
2.5 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?
- 2.5 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Smiths Medical Cassette, flow stop free flow protection, Service Code 2K8972, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-0972-48
- Lot codes and dates
16 of 16 products
Products covered by this recall # Product as published 1 Service Code 2K8210 , Lot Number 160390175M , Exp. Date 5/9/2016 2 Service Code 2K8210 , Lot Number 160400226M , Exp. Date 5/10/2016 3 Service Code 2K8210 , Lot Number 160520170M , Exp. Date 5/22/2016 4 Service Code 2K8210 , Lot Number 160590066M , Exp. Date 5/29/2016 5 Service Code 2K8210 , Lot Number 160670046M , Exp. Date 6/5/2016 6 Service Code 2K8210 , Lot Number 160680006M , Exp. Date 6/6/2016 7 Service Code 2K8210 , Lot Number 160700027M , Exp. Date 6/8/2016 8 Service Code 2K8210 , Lot Number 160730069M , Exp. Date 6/11/2016 9 Service Code 2K8210 , Lot Number 160880217M , Exp. Date 6/27/2016 10 Service Code 2K8972 , Lot Number 160450177M , Exp. Date 5/6/2016 11 Service Code 2K8972 , Lot Number 160460196M , Exp. Date 5/7/2016 12 Service Code 2K8972 , Lot Number 160600082M , Exp. Date 5/20/2016 13 Service Code 2K8972 , Lot Number 160670061C , Exp. Date 5/28/2016 14 Service Code 2K8972 , Lot Number 160740067C , Exp. Date 6/4/2016 15 Service Code 2K8972 , Lot Number 160810085C , Exp. Date 6/11/2016 16 Service Code 2K8972 , Lot Number 160950188M , Exp. Date 6/25/2016 - Amount recalled
- 220 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.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new produce recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.