Reported Jul 27, 2016 · Terminated
2 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; Service Code 2H8125 ,…
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?
14 of 14 products
| # | Product as published |
|---|---|
| 1 | 2 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride |
| 2 | Service Code 2H8125 , NDC 61553-125-52 , 100 ml in 100 ml Hospira LifeCare Bag |
| 3 | Service Code 2H8204 , NDC 61553-204-54 , 200 ml in 250 ml Hospira LifeCare Bag |
| 4 | Service Code 2H8205 , NDC 61553-205-50 , 250 ml in 250 ml Hospira LifeCare Bag |
| 5 | Service Code 2K8104 , NDC 61553-104-03 , 500 ml in 500 ml Baxter Intravia Bag |
| 6 | Service Code 2K8124 , NDC 61553-124-48 , 100 ml in 150 ml Baxter Intravia Bag |
| 7 | Service Code 2K8204 , NDC 61553-204-37 , 200 ml in 250 ml Baxter Intravia Bag |
| 8 | Service Code 2K8205 , NDC 61553-205-02 , 250 ml in 250 ml Baxter Intravia Bag |
| 9 | Service Code 2K8443 , NDC 61553-443-47 , 150 ml in 150 ml Baxter Intravia Bag |
| 10 | Service Code 2K8491 , NDC 61553-491-30 , 125 ml in 150 ml Baxter Intravia Bag |
| 11 | Service Code 2K9491 , NDC 61553-491-96 , 100 ml in 150 ml Baxter Intravia Bag |
| 12 | Service Code 2K9802 , NDC 61553-802-96 , 100 ml in 150 ml Baxter Intravia Bag |
| 13 | Service Code 4J8205 , NDC 61553-205-97 , 250 ml in 250 ml Baxter Intravia Bag |
| 14 | Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141 |
- Lot codes and dates
475 of 475 products
Products covered by this recall # Product as published 1 Service Code 3V8705 , Lot Number 160380161M , Exp. Date 5/8/2016 2 Service Code 3V8705 , Lot Number 160400200M , Exp. Date 5/10/2016 3 Service Code 3V8705 , Lot Number 160460205M , Exp. Date 5/15/2016 4 Service Code 3V8705 , Lot Number 160530278M , Exp. Date 5/23/2016 5 Service Code 3V8705 , Lot Number 160610204M , Exp. Date 5/31/2016 6 Service Code 3V8705 , Lot Number 160630155M , Exp. Date 6/2/2016 7 Service Code 3V8705 , Lot Number 160700159M , Exp. Date 6/9/2016 8 Service Code 3V8705 , Lot Number 160770234M , Exp. Date 6/16/2016 9 Service Code 3V8705 , Lot Number 160800199M , Exp. Date 6/19/2016 10 Service Code 3V8705 , Lot Number 160840217M , Exp. Date 6/23/2016 11 Service Code 3V8705 , Lot Number 161080171M , Exp. Date 7/17/2016 12 Service Code 3V8707 , Lot Number 160460233M , Exp. Date 5/10/2016 13 Service Code 3V8707 , Lot Number 160530170M , Exp. Date 5/17/2016 14 Service Code 3V8707 , Lot Number 160660139M , Exp. Date 5/30/2016 15 Service Code 3V8707 , Lot Number 160670160M , Exp. Date 5/31/2016 16 Service Code 3V8707 , Lot Number 160730245M , Exp. Date 6/6/2016 17 Service Code 3V8707 , Lot Number 160810188M , Exp. Date 6/14/2016 18 Service Code 3V8707 , Lot Number 160880197M , Exp. Date 6/21/2016 19 Service Code 3V8707 , Lot Number 160940223M , Exp. Date 6/27/2016 20 Service Code 3V8707 , Lot Number 160960010M , Exp. Date 6/28/2016 - Amount recalled
- 97,716 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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