Reported Jul 27, 2016 · Terminated
2 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Service Code 2C8201 , NDC…
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?
- 2 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Service Code 2C8201 , NDC 61553-201-58 , 200 ml in 250 ml Cormix Bag ; Service Code 2H8131 , NDC 61553-131-50 , 250 ml in 250 ml Hospira LifeCare Bag ; Service Code 2H8201 , NDC 61553-201-54 , 200 ml in 250 ml Hospira LifeCare Bag ; Service Code 2K8122 , NDC 61553-122-48 , 100 ml in 100 ml Baxter APII Bag ; Service Code 2K8123 , NDC 61553-123-48 , 100 ml in 150 ml Baxter Intravia Bag ; Service Code 2K8131 , NDC 61553-131-02 , 250 ml in 250 ml Baxter Intravia Bag ; Service Code 2K8201 , NDC 61553-201-37 , 200 ml in 250 ml Baxter Intravia Bag ; Service Code 2K8442 , NDC 61553-442-30 , 125 ml in 150 ml Baxter Intravia Bag ; Service Code 2K8490 , NDC 61553-490-47150 ml in 150 ml Baxter Intravia Bag, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141
- Lot codes and dates
268 of 268 products
Products covered by this recall # Product as published 1 Service Code 3V8701 , Lot Number 160390095M , Exp. Date 5/9/2016 2 Service Code 3V8701 , Lot Number 160480198M , Exp. Date 5/18/2016 3 Service Code 3V8701 , Lot Number 160540108M , Exp. Date 5/24/2016 4 Service Code 3V8701 , Lot Number 160690111M , Exp. Date 6/8/2016 5 Service Code 3V8701 , Lot Number 160740250M , Exp. Date 6/13/2016 6 Service Code 3V8701 , Lot Number 160820104M , Exp. Date 6/21/2016 7 Service Code 3V8701 , Lot Number 160900119M , Exp. Date 6/28/2016 8 Service Code 3V8701 , Lot Number 160970024M , Exp. Date 7/5/2016 9 Service Code 3V8703 , Lot Number 160420127M , Exp. Date 5/6/2016 10 Service Code 3V8703 , Lot Number 160460220M , Exp. Date 5/10/2016 11 Service Code 3V8703 , Lot Number 160530317M , Exp. Date 5/17/2016 12 Service Code 3V8703 , Lot Number 160540155M , Exp. Date 5/18/2016 13 Service Code 3V8703 , Lot Number 160630132M , Exp. Date 5/27/2016 14 Service Code 3V8703 , Lot Number 160660018C , Exp. Date 5/30/2016 15 Service Code 3V8703 , Lot Number 160660249M , Exp. Date 5/30/2016 16 Service Code 3V8703 , Lot Number 160750261M , Exp. Date 6/8/2016 17 Service Code 3V8703 , Lot Number 160800218M , Exp. Date 6/13/2016 18 Service Code 3V8703 , Lot Number 160910144M , Exp. Date 6/24/2016 19 Service Code 3V8703 , Lot Number 160940249M , Exp. Date 6/27/2016 20 Service Code 3V8703 , Lot Number 161080258M , Exp. Date 7/11/2016 - Amount recalled
- 43,589 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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