Reported Jul 27, 2016 · Terminated
5 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride 50 mL in 60 mL BD…
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?
- 5 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride 50 mL in 60 mL BD Syringe, Service Code 2T6140 (NDC 61553-140-20) , 60 mL in 60 mL BD Syringe, Service Code 2T6222 (NDC 61553-222-31), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141
- Lot codes and dates
84 of 84 products
Products covered by this recall # Product as published 1 Service Code 2H8139 , Lot Number 160420171M , Exp. Date 5/12/2016 2 Service Code 2H8139 , Lot Number 160460111M , Exp. Date 5/16/2016 3 Service Code 2H8139 , Lot Number 160490001M , Exp. Date 5/18/2016 4 Service Code 2H8139 , Lot Number 160530289M , Exp. Date 5/23/2016 5 Service Code 2H8139 , Lot Number 160560215M , Exp. Date 5/26/2016 6 Service Code 2H8139 , Lot Number 160590055M , Exp. Date 5/29/2016 7 Service Code 2H8139 , Lot Number 160600232M , Exp. Date 5/30/2016 8 Service Code 2H8139 , Lot Number 160610189M , Exp. Date 5/31/2016 9 Service Code 2H8139 , Lot Number 160670159M , Exp. Date 6/6/2016 10 Service Code 2H8139 , Lot Number 160740151M , Exp. Date 6/13/2016 11 Service Code 2H8139 , Lot Number 160770172M , Exp. Date 6/16/2016 12 Service Code 2H8139 , Lot Number 160800069M , Exp. Date 6/18/2016 13 Service Code 2H8139 , Lot Number 160810208M , Exp. Date 6/20/2016 14 Service Code 2H8139 , Lot Number 160900168M , Exp. Date 6/29/2016 15 Service Code 2H8139 , Lot Number 160960158M , Exp. Date 7/5/2016 16 Service Code 2H8139 , Lot Number 161080229M , Exp. Date 7/17/2016 17 Service Code 2H8140 , Lot Number 160450212M , Exp. Date 5/11/2016 18 Service Code 2H8140 , Lot Number 160550237M , Exp. Date 5/21/2016 19 Service Code 2H8140 , Lot Number 160660222M , Exp. Date 6/1/2016 20 Service Code 2H8140 , Lot Number 160670248M , Exp. Date 6/2/2016 - Amount recalled
- 3,927 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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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