Reported Jul 27, 2016 · Terminated
5 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride Service Code 2K8135 ,…
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?
7 of 7 products
| # | Product as published |
|---|---|
| 1 | 5 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride Service Code 2K8135 , NDC 61553-135-48 , 100 ml in 150 ml Baxter Intravia Bag |
| 2 | Service Code 2K8136 , NDC 61553-136-02 , 250 ml in 250 ml Baxter Intravia Bag |
| 3 | Service Code 2K8447 , NDC 61553-447-25 , 500 ml in 500 ml Baxter Intravia Bag |
| 4 | Service Code 2K9135 , NDC 61553-135-10 , 350 ml in 500 ml Baxter Intravia Bag |
| 5 | Service Code 2K9915 , NDC 61553-915-97 , 250 ml in 250 ml Baxter Intravia Bag |
| 6 | Service Code 4J8136 , NDC 61553-136-97 , 250 ml in 250 ml Baxter Intravia Bag |
| 7 | Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141 |
- Lot codes and dates
75 of 75 products
Products covered by this recall # Product as published 1 Service Code 2H8136 , Lot Number 160390196M , Exp. Date 5/9/2016 2 Service Code 2H8136 , Lot Number 160400231M , Exp. Date 5/10/2016 3 Service Code 2H8136 , Lot Number 160410114M , Exp. Date 5/11/2016 4 Service Code 2H8136 , Lot Number 160460187M , Exp. Date 5/16/2016 5 Service Code 2H8136 , Lot Number 160490237M , Exp. Date 5/19/2016 6 Service Code 2H8136 , Lot Number 160520172M , Exp. Date 5/22/2016 7 Service Code 2H8136 , Lot Number 160530288M , Exp. Date 5/23/2016 8 Service Code 2H8136 , Lot Number 160600186M , Exp. Date 5/30/2016 9 Service Code 2H8136 , Lot Number 160630207M , Exp. Date 6/2/2016 10 Service Code 2H8136 , Lot Number 160670243M , Exp. Date 6/6/2016 11 Service Code 2H8136 , Lot Number 160730070M , Exp. Date 6/11/2016 12 Service Code 2H8136 , Lot Number 160740213M , Exp. Date 6/13/2016 13 Service Code 2H8136 , Lot Number 160810151M , Exp. Date 6/20/2016 14 Service Code 2H8136 , Lot Number 160830114M , Exp. Date 6/22/2016 15 Service Code 2H8136 , Lot Number 160880266M , Exp. Date 6/27/2016 16 Service Code 2H8136 , Lot Number 160950223M , Exp. Date 7/4/2016 17 Service Code 2H8136 , Lot Number 160960179M , Exp. Date 7/5/2016 18 Service Code 2H8136 , Lot Number 161080119M , Exp. Date 7/17/2016 19 Service Code 2K8135 , Lot Number 160390318M , Exp. Date 5/9/2016 20 Service Code 2K8135 , Lot Number 160450256M , Exp. Date 5/15/2016 - Amount recalled
- 3,474 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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