Reported Jul 27, 2016 · Terminated
10 mcg/mL HYDROmorphone HCl and 0.125% 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?
- 10 mcg/mL HYDROmorphone HCl and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8908, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-908-02 ,
- Lot codes and dates
18 of 18 products
Products covered by this recall # Product as published 1 Service Code 2K8482 , Lot Number 160400113M , Exp. Date 5/10/2016 2 Service Code 2K8482 , Lot Number 160460097M , Exp. Date 5/16/2016 3 Service Code 2K8482 , Lot Number 160470229M , Exp. Date 5/17/2016 4 Service Code 2K8482 , Lot Number 160530109M , Exp. Date 5/23/2016 5 Service Code 2K8482 , Lot Number 160630133M , Exp. Date 6/2/2016 6 Service Code 2K8482 , Lot Number 160670166M , Exp. Date 6/6/2016 7 Service Code 2K8482 , Lot Number 160680146M , Exp. Date 6/7/2016 8 Service Code 2K8482 , Lot Number 160750150M , Exp. Date 6/14/2016 9 Service Code 2K8482 , Lot Number 160810139M , Exp. Date 6/20/2016 10 Service Code 2K8482 , Lot Number 160910246M , Exp. Date 6/30/2016 11 Service Code 2K8482 , Lot Number 160960036C , Exp. Date 7/5/2016 12 Service Code 2K8482 , Lot Number 160970147M , Exp. Date 7/6/2016 13 Service Code 2K8482 , Lot Number 161080277M , Exp. Date 7/17/2016 14 Service Code 2K8908 , Lot Number 160940041C , Exp. Date 5/10/2016 15 Service Code 2K8908 , Lot Number 160950030C , Exp. Date 5/11/2016 16 Service Code 2T6482 , Lot Number 160560209M , Exp. Date 5/26/2016 17 Service Code 2T6482 , Lot Number 160590158M , Exp. Date 5/29/2016 18 Service Code 2T6482 , Lot Number 160750214M , Exp. Date 6/14/2016 - Amount recalled
- 1,277 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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