Reported Jul 27, 2016 · Terminated
0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, a) 250 mL Hospira LifeCare Bag (NDC 61553-197-50),…
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?
6 of 6 products
| # | Product as published |
|---|---|
| 1 | 250 mL Hospira LifeCare Bag (NDC 61553-197-50) |
| 2 | 250 mL Hospira LifeCare Bag (NDC 61553-197-50) |
| 3 | 150 mL Baxter Intravia Bag (NDC 61553-189-48) |
| 4 | 250 mL Baxter VIAFLEX Bag ( NDC 61553-197-02) |
| 5 | 250 mL White Smiths Medical Cassette (NDC 615530-933-11) |
| 6 | 250 mL Yellow Smiths Medical Cassette (NDC 61553-190-50), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141 |
- Lot codes and dates
41 of 41 products
Products covered by this recall # Product as published 1 Service Code 2H8197 , Lot Number 160730048M , Exp. Date 6/12/2016 2 Service Code 2H8197 , Lot Number 160840111M , Exp. Date 6/22/2016 3 Service Code 2H8197 , Lot Number 160870066M , Exp. Date 6/25/2016 4 Service Code 2H8197 , Lot Number 160880208M , Exp. Date 6/27/2016 5 Service Code 2H8197 , Lot Number 160910038M , Exp. Date 6/29/2016 6 Service Code 2K8189 , Lot Number 160730049M , Exp. Date 6/11/2016 7 Service Code 2K8189 , Lot Number 160810152M , Exp. Date 6/20/2016 8 Service Code 2K8189 , Lot Number 160820330M , Exp. Date 6/21/2016 9 Service Code 2K8189 , Lot Number 160940135M , Exp. Date 7/3/2016 10 Service Code 2K8189 , Lot Number 160960178M , Exp. Date 7/5/2016 11 Service Code 2K8189 , Lot Number 160970201M , Exp. Date 7/6/2016 12 Service Code 2K8197 , Lot Number 160660178M , Exp. Date 6/5/2016 13 Service Code 2K8197 , Lot Number 160670161M , Exp. Date 6/6/2016 14 Service Code 2K8197 , Lot Number 160730253M , Exp. Date 6/12/2016 15 Lot # 160770186M 16 Exp. 06/16 Lot # 160810189M 17 Exp. 06/16 Lot # 160840050M 18 Exp. 06/16 Lot # 160890231M 19 Exp. 06/16 Lot # 160910228M 20 Exp. 06/16 Lot # 160560020M - Amount recalled
- 2,194 bags and 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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