Reported Jul 27, 2016 · Terminated
4 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 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 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8126 (NDC 61553-126-50), Service Code 2K8127 (NDC 61553-127-02, 125 mL in 150 mL Baxter Intravia Bag, Service Code 2K8211 (NDC 61553-211-08), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141
- Lot codes and dates
19 of 19 products
Products covered by this recall # Product as published 1 Service Code 2H8126 , Lot Number 161080146M , Exp. Date 7/17/2016 2 Service Code 2K8127 , Lot Number 160460115M , Exp. Date 5/10/2016 3 Service Code 2K8127 , Lot Number 160560222M , Exp. Date 5/20/2016 4 Service Code 2K8127 , Lot Number 160610209M , Exp. Date 5/25/2016 5 Service Code 2K8127 , Lot Number 160620148M , Exp. Date 5/26/2016 6 Service Code 2K8127 , Lot Number 160660062M , Exp. Date 5/29/2016 7 Service Code 2K8127 , Lot Number 160680154M , Exp. Date 6/1/2016 8 Service Code 2K8127 , Lot Number 160690126M , Exp. Date 6/2/2016 9 Service Code 2K8127 , Lot Number 160740153M , Exp. Date 6/7/2016 10 Service Code 2K8127 , Lot Number 160800064M , Exp. Date 6/12/2016 11 Service Code 2K8127 , Lot Number 160810161M , Exp. Date 6/14/2016 12 Service Code 2K8127 , Lot Number 160880187M , Exp. Date 6/21/2016 13 Service Code 2K8127 , Lot Number 160950226M , Exp. Date 6/28/2016 14 Service Code 2K8127 , Lot Number 160960154M , Exp. Date 6/29/2016 15 Service Code 2K8211 , Lot Number 160530215M , Exp. Date 5/23/2016 16 Service Code 2K8211 , Lot Number 160590067M , Exp. Date 5/29/2016 17 Service Code 2K8211 , Lot Number 160750033M , Exp. Date 6/13/2016 18 Service Code 2K8211 , Lot Number 160880261M , Exp. Date 6/27/2016 19 Service Code 2K8211 , Lot Number 160910039M , Exp. Date 6/29/2016 - Amount recalled
- 455 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.
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.