Reported Jul 27, 2016 · Terminated
0.15% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Yellow Smiths Medical Cassette,…
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?
- 0.15% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Yellow Smiths Medical Cassette, flow stop free-flow protection, Service Code 2T8217, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-217-50
- Lot codes and dates
22 of 22 products
Products covered by this recall # Product as published 1 Lot Number 160380121M , Exp. Date 5/7/2016 2 Lot Number 160420113M , Exp. Date 5/11/2016 3 Lot Number 160450116M , Exp. Date 5/15/2016 4 Lot Number 160470127M , Exp. Date 5/16/2016 5 Lot Number 160480136M , Exp. Date 5/18/2016 6 Lot Number 160490132M , Exp. Date 5/18/2016 7 Lot Number 160520114M , Exp. Date 5/21/2016 8 Lot Number 160530129M , Exp. Date 5/23/2016 9 Lot Number 160590138M , Exp. Date 5/29/2016 10 Lot Number 160600038C , Exp. Date 5/30/2016 11 Lot Number 160620018C , Exp. Date 6/1/2016 12 Lot Number 160700020C , Exp. Date 6/9/2016 13 Lot Number 160740044C , Exp. Date 6/13/2016 14 Lot Number 160750033C , Exp. Date 6/14/2016 15 Lot Number 160760051C , Exp. Date 6/15/2016 16 Lot Number 160770024C , Exp. Date 6/16/2016 17 Lot Number 160810053C , Exp. Date 6/20/2016 18 Lot Number 160820033C , Exp. Date 6/21/2016 19 Lot Number 160880014C , Exp. Date 6/27/2016 20 Lot Number 160940015C , Exp. Date 7/2/2016 - Amount recalled
- 315 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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