Reported Jul 27, 2016 · Terminated
1 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 150 mL in 150 mL…
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?
- 1 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 150 mL in 150 mL Baxter Intravia Bag, Service Code 2K9998, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-998-95
- Lot codes and dates
24 of 24 products
Products covered by this recall # Product as published 1 Service Code 2K9998 , Lot Number 160460135M , Exp. Date 5/10/2016 2 Service Code 2K9998 , Lot Number 160530146M , Exp. Date 5/17/2016 3 Service Code 2K9998 , Lot Number 160590137M , Exp. Date 5/23/2016 4 Service Code 2K9998 , Lot Number 160660221M , Exp. Date 5/30/2016 5 Service Code 2K9998 , Lot Number 160730163M , Exp. Date 6/6/2016 6 Service Code 2K9998 , Lot Number 160870147M , Exp. Date 6/20/2016 7 Service Code 2K9998 , Lot Number 160880265M , Exp. Date 6/21/2016 8 Service Code 2K9998 , Lot Number 160940206M , Exp. Date 6/27/2016 9 Service Code 2K9998 , Lot Number 161080210M , Exp. Date 7/11/2016 10 Service Code 2T8998 , Lot Number 160460267M , Exp. Date 5/7/2016 11 Service Code 2T8998 , Lot Number 160470042M , Exp. Date 5/8/2016 12 Service Code 2T8998 , Lot Number 160530034M , Exp. Date 5/14/2016 13 Service Code 2T8998 , Lot Number 160610043M , Exp. Date 5/22/2016 14 Service Code 2T8998 , Lot Number 160640008M , Exp. Date 5/24/2016 15 Service Code 2T8998 , Lot Number 160690011C , Exp. Date 5/30/2016 16 Service Code 2T8998 , Lot Number 160690012C , Exp. Date 5/30/2016 17 Service Code 2T8998 , Lot Number 160740064C , Exp. Date 6/4/2016 18 Service Code 2T8998 , Lot Number 160810066C , Exp. Date 6/11/2016 19 Service Code 2T8998 , Lot Number 160840030C , Exp. Date 6/14/2016 20 Service Code 2T8998 , Lot Number 160880042C , Exp. Date 6/18/2016 - Amount recalled
- 1,527 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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