Reported Jul 27, 2016 · Terminated
0.25% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; , Service Code 2H8120 , NDC 61553-120-50 , 250 ml in…
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?
9 of 9 products
| # | Product as published |
|---|---|
| 1 | 25% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride |
| 2 | Service Code 2H8120 , NDC 61553-120-50 , 250 ml in 250 ml Hospira LifeCare Bag |
| 3 | Service Code 2H8243 , NDC 61553-243-54 , 200 ml in 250 ml Hospira LifeCare Bag |
| 4 | Service Code 2K8120 , NDC 61553-120-09 , 400 ml in 500 ml Baxter Intravia Bag |
| 5 | Service Code 2K8243 , NDC 61553-243-37 , 200 ml in 250 ml Baxter Intravia Bag |
| 6 | Service Code 2K9120 , NDC 61553-120-03 , 500 ml in 500 ml Baxter Intravia Bag |
| 7 | Service Code 2N1120 , NDC 61553-120-84 , 400 ml in 500 ml Baxter Intravia Bag |
| 8 | Service Code 2N9619 , NDC 61553-619-97 , 250 ml in 250 ml Baxter Intravia Bag |
| 9 | Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141 |
- Lot codes and dates
88 of 88 products
Products covered by this recall # Product as published 1 Service Code 2H8120 , Lot Number 160380137M , Exp. Date 5/8/2016 2 Service Code 2H8120 , Lot Number 160420181M , Exp. Date 5/12/2016 3 Service Code 2H8120 , Lot Number 160450166M , Exp. Date 5/15/2016 4 Service Code 2H8120 , Lot Number 160460209M , Exp. Date 5/16/2016 5 Service Code 2H8120 , Lot Number 160600277M , Exp. Date 5/30/2016 6 Service Code 2H8120 , Lot Number 160610057M , Exp. Date 5/30/2016 7 Service Code 2H8120 , Lot Number 160610224M , Exp. Date 5/31/2016 8 Service Code 2H8120 , Lot Number 160680153M , Exp. Date 6/7/2016 9 Service Code 2H8120 , Lot Number 160810219M , Exp. Date 6/20/2016 10 Service Code 2H8120 , Lot Number 160910124M , Exp. Date 6/29/2016 11 Service Code 2H8120 , Lot Number 160960220M , Exp. Date 7/5/2016 12 Service Code 2H8243 , Lot Number 160530200M , Exp. Date 5/9/2016 13 Service Code 2H8243 , Lot Number 160600047M , Exp. Date 5/16/2016 14 Service Code 2H8243 , Lot Number 160670033M , Exp. Date 5/22/2016 15 Service Code 2H8243 , Lot Number 160810051M , Exp. Date 6/5/2016 16 Service Code 2H8243 , Lot Number 160880267M , Exp. Date 6/13/2016 17 Service Code 2H8243 , Lot Number 160910035M , Exp. Date 6/15/2016 18 Service Code 2H8243 , Lot Number 160950059M , Exp. Date 6/19/2016 19 Service Code 2K8120 , Lot Number 160480190M , Exp. Date 5/18/2016 20 Service Code 2K8120 , Lot Number 160550194M , Exp. Date 5/25/2016 - Amount recalled
- 2,874 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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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