Reported Jul 27, 2016 · Terminated
5 mcg/mL HYDROmorphone HCl and 0.0625% 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?
- 5 mcg/mL HYDROmorphone HCl and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8483, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-483-61
- Lot codes and dates
10 of 10 products
Products covered by this recall # Product as published 1 Lot Number 160380152M , Exp. Date 5/8/2016 2 Lot Number 160400233M , Exp. Date 5/10/2016 3 Lot Number 160540186M , Exp. Date 5/24/2016 4 Lot Number 160660046M , Exp. Date 6/4/2016 5 Lot Number 160730154M , Exp. Date 6/12/2016 6 Lot Number 160750176M , Exp. Date 6/14/2016 7 Lot Number 160760046M , Exp. Date 6/14/2016 8 Lot Number 160800066M , Exp. Date 6/18/2016 9 Lot Number 160820111M , Exp. Date 6/20/2016 10 Lot Number 160960039M , Exp. Date 7/4/2016 - Amount recalled
- 115 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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