Reported Jul 27, 2016 · Terminated
2 mcg/mL Fentanyl Citrate and 0.083% 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 mcg/mL Fentanyl Citrate and 0.083% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Yellow Smiths Medical Cassette, Service Code 2K8871(NDC 61553-871-48), 250 mL in 250 mL Yellow Smiths Medical Cassette, Service Code 2T8871 (NDC 61553-871-50), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141
- Lot codes and dates
16 of 16 products
Products covered by this recall # Product as published 1 Service Code 2K8176 , Lot Number 160460099M , Exp. Date 5/10/2016 2 Service Code 2K8176 , Lot Number 160480269M , Exp. Date 5/12/2016 3 Service Code 2K8176 , Lot Number 160560160M , Exp. Date 5/20/2016 4 Service Code 2K8176 , Lot Number 160630171M , Exp. Date 5/27/2016 5 Service Code 2K8176 , Lot Number 160690141M , Exp. Date 6/2/2016 6 Service Code 2K8176 , Lot Number 160740128M , Exp. Date 6/7/2016 7 Service Code 2K8176 , Lot Number 160750247M , Exp. Date 6/8/2016 8 Service Code 2K8176 , Lot Number 160810137M , Exp. Date 6/14/2016 9 Service Code 2K8176 , Lot Number 160870187M , Exp. Date 6/20/2016 10 Service Code 2K8176 , Lot Number 160940253M , Exp. Date 6/27/2016 11 Service Code 2K8176 , Lot Number 161080131M , Exp. Date 7/11/2016 12 Service Code 2K8871 , Lot Number 160480223M , Exp. Date 5/8/2016 13 Service Code 2K8871 , Lot Number 160670054C , Exp. Date 5/28/2016 14 Service Code 2K8871 , Lot Number 160870033C , Exp. Date 6/17/2016 15 Service Code 2K8967 , Lot Number 16092001C , Exp. Date 6/21/2016 16 Service Code 2T8871 , Lot Number 160970026M , Exp. Date 5/7/2016 - Amount recalled
- 1,280 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.
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