Reported Jul 27, 2016 · Terminated
10 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride;, 10 mL in 12 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?
- 10 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride;, 10 mL in 12 mL Monoject Syringe, Service Code 2T6014 (NDC 61553-014-20), 50 mL in 60 mL BD Syringe , Service Code 2T6636 (NDC 61553-636-27), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141
- Lot codes and dates
12 of 12 products
Products covered by this recall # Product as published 1 Service Code 2T6014 , Lot Number 160390220M , Exp. Date 5/9/2016 2 Service Code 2T6014 , Lot Number 160700029M , Exp. Date 6/8/2016 3 Service Code 2T6636 , Lot Number 160380145M , Exp. Date 5/7/2016 4 Service Code 2T6636 , Lot Number 160390003M , Exp. Date 5/8/2016 5 Service Code 2T6636 , Lot Number 160460177M , Exp. Date 5/15/2016 6 Service Code 2T6636 , Lot Number 160490165M , Exp. Date 5/18/2016 7 Service Code 2T6636 , Lot Number 160550201M , Exp. Date 5/24/2016 8 Service Code 2T6636 , Lot Number 160670237M , Exp. Date 6/6/2016 9 Service Code 2T6636 , Lot Number 160680008M , Exp. Date 6/6/2016 10 Service Code 2T6636 , Lot Number 160700023M , Exp. Date 6/8/2016 11 Service Code 2T6636 , Lot Number 160710003M , Exp. Date 6/9/2016 12 Service Code 2T6636 , Lot Number 160740258M , Exp. Date 6/13/2016 - Amount recalled
- 600 Monoject Syringes
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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