Reported Jul 27, 2016 · Terminated
20 mcg/mL HYDROmorphone HCl and 0.06% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 55 mL in 60 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?
- 20 mcg/mL HYDROmorphone HCl and 0.06% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 55 mL in 60 mL Monoject Syringe, Service Code 2T6620, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-620-12
- Lot codes and dates
10 of 10 products
Products covered by this recall # Product as published 1 Service Code 2K8157 , Lot Number 160420116M , Exp. Date 5/12/2016 2 Service Code 2K8157 , Lot Number 160540135M , Exp. Date 5/24/2016 3 Service Code 2K8157 , Lot Number 160630121M , Exp. Date 6/2/2016 4 Service Code 2K8157 , Lot Number 160730218M , Exp. Date 6/12/2016 5 Service Code 2K8157 , Lot Number 160760126M , Exp. Date 6/14/2016 6 Service Code 2K8157 , Lot Number 160770152M , Exp. Date 6/16/2016 7 Service Code 2K8157 , Lot Number 160810169M , Exp. Date 6/20/2016 8 Service Code 2K8157 , Lot Number 160840206M , Exp. Date 6/23/2016 9 Service Code 2K8157 , Lot Number 160940210M , Exp. Date 7/3/2016 10 Service Code 2T6620 , Lot Number 160900133M , Exp. Date 5/6/2016 - Amount recalled
- 435 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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