Reported Jul 27, 2016 · Terminated
5 mcg/mL Fentanyl Citrate and 0.04% 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?
- 5 mcg/mL Fentanyl Citrate and 0.04% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Yellow Smiths Medical Cassette, flow stop free-flow protection, Service Code 2K8809, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-809-48
- Lot codes and dates
19 of 19 products
Products covered by this recall # Product as published 1 Lot Number 160460023M , Exp. Date 5/7/2016 2 Lot Number 160460024M , Exp. Date 5/7/2016 3 Lot Number 160460025M , Exp. Date 5/7/2016 4 Lot Number 160460328M , Exp. Date 5/7/2016 5 Lot Number 160540052M , Exp. Date 5/15/2016 6 Lot Number 160600338M , Exp. Date 5/21/2016 7 Lot Number 160600339M , Exp. Date 5/21/2016 8 Lot Number 160600340M , Exp. Date 5/21/2016 9 Lot Number 160600341M , Exp. Date 5/21/2016 10 Lot Number 160680065C , Exp. Date 5/29/2016 11 Lot Number 160750039C , Exp. Date 6/5/2016 12 Lot Number 160750040C , Exp. Date 6/5/2016 13 Lot Number 160750041C , Exp. Date 6/5/2016 14 Lot Number 160770040C , Exp. Date 6/7/2016 15 Lot Number 160880030C , Exp. Date 6/18/2016 16 Lot Number 160880031C , Exp. Date 6/18/2016 17 Lot Number 160880032C , Exp. Date 6/17/2016 18 Lot Number 160880033C , Exp. Date 6/18/2016 19 Lot Number 160880034C , Exp. Date 6/18/2016 - Amount recalled
- 2,256 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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