Reported Jul 27, 2016 · Terminated
0.2% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 400 mL in 500 mL Baxter Intravia Bag , Service Code…
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?
- 0.2% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 400 mL in 500 mL Baxter Intravia Bag , Service Code 2K8119 (NDC 61553-119-09), 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8171(NDC 61553-171-37)150 mL in 150 mL Baxter Intravia Bag, Service Code 2K8463 (NDC 61553-463-47), 250 mL in 250 mL Yellow Smiths Medical Cassette, flow stop free-flow protection, Service Code 2K8931(NDC 61553-931-02), 400 ml in 500 mL Baxter Intravia Bag, Service Code 2N1119, (NDC 61553-119-84), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, ;
- Lot codes and dates
26 of 26 products
Products covered by this recall # Product as published 1 Service Code 2K8119 , Lot Number 160480208M , Exp. Date 5/18/2016 2 Service Code 2K8119 , Lot Number 160490134M , Exp. Date 5/19/2016 3 Service Code 2K8119 , Lot Number 160520129M , Exp. Date 5/22/2016 4 Service Code 2K8119 , Lot Number 160530167M , Exp. Date 5/23/2016 5 Service Code 2K8119 , Lot Number 160700126M , Exp. Date 6/8/2016 6 Service Code 2K8119 , Lot Number 160740148M , Exp. Date 6/13/2016 7 Service Code 2K8119 , Lot Number 160750046M , Exp. Date 6/13/2016 8 Service Code 2K8119 , Lot Number 160820124M , Exp. Date 6/21/2016 9 Service Code 2K8171 , Lot Number 160880264M , Exp. Date 6/27/2016 10 Service Code 2K8217 , Lot Number 160380114M , Exp. Date 5/8/2016 11 Service Code 2K8217 , Lot Number 160410116M , Exp. Date 5/11/2016 12 Service Code 2K8217 , Lot Number 160480128M , Exp. Date 5/18/2016 13 Service Code 2K8217 , Lot Number 160540123M , Exp. Date 5/23/2016 14 Service Code 2K8217 , Lot Number 160600196M , Exp. Date 5/30/2016 15 Service Code 2K8217 , Lot Number 160730054M , Exp. Date 6/12/2016 16 Service Code 2K8217 , Lot Number 160740245M , Exp. Date 6/13/2016 17 Service Code 2K8217 , Lot Number 160750048M , Exp. Date 6/13/2016 18 Service Code 2K8217 , Lot Number 160840149M , Exp. Date 6/23/2016 19 Service Code 2K8217 , Lot Number 160900131M , Exp. Date 6/29/2016 20 Service Code 2K8217 , Lot Number 160960139M , Exp. Date 7/5/2016 - Amount recalled
- 355 bags
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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