Reported Jul 27, 2016 · Terminated
4 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride 50 mL in 60 mL Monoject…
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 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride 50 mL in 60 mL Monoject Syringe, Service Code 2K8983, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-983-48
- Lot codes and dates
38 of 38 products
Products covered by this recall # Product as published 1 Service Code 2H8267 , Lot Number 160630024M , Exp. Date 5/28/2016 2 Service Code 2K8128 , Lot Number 160490252M , Exp. Date 5/13/2016 3 Service Code 2K8128 , Lot Number 160530274M , Exp. Date 5/17/2016 4 Service Code 2K8128 , Lot Number 160600213M , Exp. Date 5/24/2016 5 Service Code 2K8128 , Lot Number 160660184M , Exp. Date 5/30/2016 6 Service Code 2K8128 , Lot Number 160730236M , Exp. Date 6/6/2016 7 Service Code 2K8128 , Lot Number 160810218M , Exp. Date 6/14/2016 8 Service Code 2K8128 , Lot Number 160820186M , Exp. Date 6/15/2016 9 Service Code 2K8128 , Lot Number 160940172M , Exp. Date 6/27/2016 10 Service Code 2K8267 , Lot Number 160450259M , Exp. Date 5/15/2016 11 Service Code 2K8267 , Lot Number 160540156M , Exp. Date 5/24/2016 12 Service Code 2K8267 , Lot Number 160600323M , Exp. Date 5/30/2016 13 Service Code 2K8267 , Lot Number 160660257M , Exp. Date 6/5/2016 14 Service Code 2K8267 , Lot Number 160730258M , Exp. Date 6/12/2016 15 Service Code 2K8267 , Lot Number 160770130M , Exp. Date 6/16/2016 16 Service Code 2K8267 , Lot Number 160840132M , Exp. Date 6/23/2016 17 Service Code 2K8267 , Lot Number 160900007M , Exp. Date 6/28/2016 18 Service Code 2K8267 , Lot Number 160970143M , Exp. Date 7/6/2016 19 Service Code 2K8267 , Lot Number 161080249M , Exp. Date 7/17/2016 20 Service Code 2K8638 , Lot Number 160410229M , Exp. Date 5/11/2016 - Amount recalled
- 3,828 syringes
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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