Reported Jul 27, 2016 · Terminated
10 mcg/mL HYDROmorphone HCl and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 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?
- 10 mcg/mL HYDROmorphone HCl and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Yellow Smiths Medical Cassette (stop free-flow protection), Service Code 2K8909, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-909-02 ,
- Lot codes and dates
32 of 32 products
Products covered by this recall # Product as published 1 Service Code 2H8481 , Lot Number 160460180M , Exp. Date 5/16/2016 2 Service Code 2H8481 , Lot Number 160540181M , Exp. Date 5/24/2016 3 Service Code 2H8481 , Lot Number 160830170M , Exp. Date 6/22/2016 4 Service Code 2K8481 , Lot Number 160380110M , Exp. Date 5/8/2016 5 Service Code 2K8481 , Lot Number 160390206M , Exp. Date 5/9/2016 6 Service Code 2K8481 , Lot Number 160400241M , Exp. Date 5/10/2016 7 Service Code 2K8481 , Lot Number 160410170M , Exp. Date 5/11/2016 8 Service Code 2K8481 , Lot Number 160450130M , Exp. Date 5/15/2016 9 Service Code 2K8481 , Lot Number 160480181M , Exp. Date 5/18/2016 10 Service Code 2K8481 , Lot Number 160520033M , Exp. Date 5/22/2016 11 Service Code 2K8481 , Lot Number 160530127M , Exp. Date 5/23/2016 12 Service Code 2K8481 , Lot Number 160540137M , Exp. Date 5/24/2016 13 Service Code 2K8481 , Lot Number 160560212M , Exp. Date 5/26/2016 14 Service Code 2K8481 , Lot Number 160600294M , Exp. Date 5/30/2016 15 Service Code 2K8481 , Lot Number 160610237M , Exp. Date 5/31/2016 16 Service Code 2K8481 , Lot Number 160630118M , Exp. Date 6/2/2016 17 Service Code 2K8481 , Lot Number 160660175M , Exp. Date 6/5/2016 18 Service Code 2K8481 , Lot Number 160670245M , Exp. Date 6/6/2016 19 Service Code 2K8481 , Lot Number 160730063M , Exp. Date 6/12/2016 20 Service Code 2K8481 , Lot Number 160770227M , Exp. Date 6/16/2016 - Amount recalled
- 1,234 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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