Reported Jul 27, 2016 · Terminated
3 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 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?
- 3 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8239 (NDC 61553-239-50), 250 mL in 250 Baxter Intravia Bag, Service Code 2K8239 (NDC 61553-239-02), 150 mL in 150 mL Baxter Intravia Bag, Service Code 2K8284 (NDC 61553-284-01), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141
- Lot codes and dates
23 of 23 products
Products covered by this recall # Product as published 1 Service Code 2H8239 , Lot Number 160400232M , Exp. Date 5/10/2016 2 Service Code 2H8239 , Lot Number 160630193M , Exp. Date 6/2/2016 3 Service Code 2K8239 , Lot Number 160520143M , Exp. Date 5/16/2016 4 Service Code 2K8239 , Lot Number 160530306M , Exp. Date 5/17/2016 5 Service Code 2K8239 , Lot Number 160610250M , Exp. Date 5/25/2016 6 Service Code 2K8239 , Lot Number 160630167M , Exp. Date 5/27/2016 7 Service Code 2K8239 , Lot Number 160680214M , Exp. Date 6/1/2016 8 Service Code 2K8239 , Lot Number 160750241M , Exp. Date 6/8/2016 9 Service Code 2K8239 , Lot Number 160820181M , Exp. Date 6/15/2016 10 Service Code 2K8239 , Lot Number 160840225M , Exp. Date 6/17/2016 11 Service Code 2K8239 , Lot Number 160900186M , Exp. Date 6/23/2016 12 Service Code 2K8239 , Lot Number 160940234M , Exp. Date 6/27/2016 13 Service Code 2K8239 , Lot Number 161080183M , Exp. Date 7/11/2016 14 Service Code 2K8284 , Lot Number 160470223M , Exp. Date 5/17/2016 15 Service Code 2K8284 , Lot Number 160520118M , Exp. Date 5/22/2016 16 Service Code 2K8284 , Lot Number 160610207M , Exp. Date 5/31/2016 17 Service Code 2K8284 , Lot Number 160620153M , Exp. Date 6/1/2016 18 Service Code 2K8284 , Lot Number 160750236M , Exp. Date 6/14/2016 19 Service Code 2K8284 , Lot Number 160770226M , Exp. Date 6/16/2016 20 Service Code 2K8284 , Lot Number 160840209M , Exp. Date 6/23/2016 - Amount recalled
- 1,470 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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