Reported Jul 27, 2016 · Terminated
20 mcg/mL HYDROmorphone HCl 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?
- 20 mcg/mL HYDROmorphone HCl and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Yellow Smiths Medical Cassette, Service Code 2K8947, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-947-48
- Lot codes and dates
37 of 37 products
Products covered by this recall # Product as published 1 Service Code 2K8158 , Lot Number 160380113M , Exp. Date 5/8/2016 2 Service Code 2K8158 , Lot Number 160410115M , Exp. Date 5/11/2016 3 Service Code 2K8158 , Lot Number 160420111M , Exp. Date 5/12/2016 4 Service Code 2K8158 , Lot Number 160450184M , Exp. Date 5/15/2016 5 Service Code 2K8158 , Lot Number 160520106M , Exp. Date 5/21/2016 6 Service Code 2K8158 , Lot Number 160530143M , Exp. Date 5/23/2016 7 Service Code 2K8158 , Lot Number 160550124M , Exp. Date 5/25/2016 8 Service Code 2K8158 , Lot Number 160560211M , Exp. Date 5/26/2016 9 Service Code 2K8158 , Lot Number 160600195M , Exp. Date 5/30/2016 10 Service Code 2K8158 , Lot Number 160620137M , Exp. Date 6/1/2016 11 Service Code 2K8158 , Lot Number 160690124M , Exp. Date 6/7/2016 12 Service Code 2K8158 , Lot Number 160730219M , Exp. Date 6/12/2016 13 Service Code 2K8158 , Lot Number 160740084C , Exp. Date 6/14/2016 14 Service Code 2K8158 , Lot Number 160770123M , Exp. Date 6/16/2016 15 Service Code 2K8158 , Lot Number 160840027M , Exp. Date 6/22/2016 16 Service Code 2K8158 , Lot Number 160870228M , Exp. Date 6/26/2016 17 Service Code 2K8158 , Lot Number 160910212M , Exp. Date 6/30/2016 18 Service Code 2K8158 , Lot Number 161080220M , Exp. Date 7/17/2016 19 Service Code 2K8495 , Lot Number 160420155M , Exp. Date 5/12/2016 20 Service Code 2K8495 , Lot Number 160490122M , Exp. Date 5/19/2016 - Amount recalled
- 555 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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