Reported Jul 27, 2016 · Terminated
3 mcg/mL Fentanyl Citrate and 0.125% 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?
- 3 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 100 mL in 100 mL Yellow Smiths Medical Cassette, Service Code 2K8837 (NDC 61553-837-48), Service Code 2K8906 (NDC 61553-906-48), Service Code 2K8963 (NDC 61553-963-48), Service Code 2K8976 (NDC 61553-976-48), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141
- Lot codes and dates
71 of 71 products
Products covered by this recall # Product as published 1 Service Code 3V8708 , Lot Number 160410168M , Exp. Date 5/11/2016 2 Service Code 3V8708 , Lot Number 160600286M , Exp. Date 5/30/2016 3 Service Code 3V8708 , Lot Number 160810284M , Exp. Date 6/20/2016 4 Service Code 3V8708 , Lot Number 160820091M , Exp. Date 6/20/2016 5 Service Code 2H8285 , Lot Number 160470170M , Exp. Date 5/13/2016 6 Service Code 2H8285 , Lot Number 160530182M , Exp. Date 5/19/2016 7 Service Code 2H8285 , Lot Number 160600296M , Exp. Date 5/26/2016 8 Service Code 2H8285 , Lot Number 160670185M , Exp. Date 6/2/2016 9 Service Code 2H8285 , Lot Number 160740253M , Exp. Date 6/9/2016 10 Service Code 2H8285 , Lot Number 160820206M , Exp. Date 6/17/2016 11 Service Code 2H8285 , Lot Number 160880254M , Exp. Date 6/23/2016 12 Service Code 2H8285 , Lot Number 160910152M , Exp. Date 6/26/2016 13 Service Code 2K8237 , Lot Number 160400261M , Exp. Date 5/10/2016 14 Service Code 2K8237 , Lot Number 160450263M , Exp. Date 5/15/2016 15 Service Code 2K8237 , Lot Number 160540239M , Exp. Date 5/24/2016 16 Service Code 2K8237 , Lot Number 160620203M , Exp. Date 6/1/2016 17 Service Code 2K8237 , Lot Number 160700152M , Exp. Date 6/9/2016 18 Service Code 2K8237 , Lot Number 160730269M , Exp. Date 6/12/2016 19 Service Code 2K8237 , Lot Number 160760207M , Exp. Date 6/15/2016 20 Service Code 2K8237 , Lot Number 160810315M , Exp. Date 6/20/2016 - Amount recalled
- 5,727 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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