Reported Jul 27, 2016 · Terminated
5 mcg/mL Fentanyl Citrate and 0.1% 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 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 50 mL in 60 mL BD Syringe, Service Code 2T6257, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-257-20
- Lot codes and dates
62 of 62 products
Products covered by this recall # Product as published 1 Service Code 2H8138 , Lot Number 160410192M , Exp. Date 5/11/2016 2 Service Code 2H8138 , Lot Number 160600314M , Exp. Date 5/30/2016 3 Service Code 2H8138 , Lot Number 160690002M , Exp. Date 6/7/2016 4 Service Code 2H8138 , Lot Number 160690191M , Exp. Date 6/8/2016 5 Service Code 2H8138 , Lot Number 160740233M , Exp. Date 6/13/2016 6 Service Code 2H8138 , Lot Number 160760163M , Exp. Date 6/14/2016 7 Service Code 2H8138 , Lot Number 160830226M , Exp. Date 6/22/2016 8 Service Code 2H8138 , Lot Number 160890256M , Exp. Date 6/28/2016 9 Service Code 2H8138 , Lot Number 160940138M , Exp. Date 7/3/2016 10 Service Code 2H8138 , Lot Number 160960197M , Exp. Date 7/5/2016 11 Service Code 2H8138 , Lot Number 161080219M , Exp. Date 7/17/2016 12 Service Code 2K8138 , Lot Number 160450061M , Exp. Date 5/9/2016 13 Service Code 2K8138 , Lot Number 160470232M , Exp. Date 5/11/2016 14 Service Code 2K8138 , Lot Number 160480268M , Exp. Date 5/12/2016 15 Service Code 2K8138 , Lot Number 160590083M , Exp. Date 5/23/2016 16 Service Code 2K8138 , Lot Number 160630170M , Exp. Date 5/27/2016 17 Service Code 2K8138 , Lot Number 160690170M , Exp. Date 6/2/2016 18 Service Code 2K8138 , Lot Number 160700150M , Exp. Date 6/3/2016 19 Service Code 2K8138 , Lot Number 160770283M , Exp. Date 6/10/2016 20 Service Code 2K8138 , Lot Number 160840146M , Exp. Date 6/17/2016 - Amount recalled
- 2,713 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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