Reported Jul 27, 2016 · Terminated
0.5% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Service Code…
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?
- 0.5% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Service Code 2N1488 (NDC 61553-488-11), 500 mL in 500 mL Baxter Intravia Bag, Service Code 2N1489 (NDC 61553-489-01)Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141
- Lot codes and dates
25 of 25 products
Products covered by this recall # Product as published 1 Service Code 2N1488 , Lot Number 160520176M , Exp. Date 5/22/2016 2 Service Code 2N1488 , Lot Number 160600059M , Exp. Date 5/30/2016 3 Service Code 2N1488 , Lot Number 160970115M , Exp. Date 7/5/2016 4 Service Code 2N1489 , Lot Number 160490027C , Exp. Date 5/19/2016 5 Service Code 2N1489 , Lot Number 160560032C , Exp. Date 5/26/2016 6 Service Code 2N1489 , Lot Number 160620024C , Exp. Date 6/1/2016 7 Service Code 2N1489 , Lot Number 160630029C , Exp. Date 6/2/2016 8 Service Code 2N1489 , Lot Number 160670059C , Exp. Date 6/6/2016 9 Service Code 2N1489 , Lot Number 160700047C , Exp. Date 6/9/2016 10 Service Code 2N1489 , Lot Number 160730025C , Exp. Date 6/12/2016 11 Service Code 2N1489 , Lot Number 160810057C , Exp. Date 6/20/2016 12 Service Code 2R3332-5 , Lot Number 160420156M , Exp. Date 5/11/2016 13 Service Code 2R3332-5 , Lot Number 160470152M , Exp. Date 5/16/2016 14 Service Code 2R3332-5 , Lot Number 160620035M , Exp. Date 5/31/2016 15 Service Code 2R3332-5 , Lot Number 160770159M , Exp. Date 6/16/2016 16 Service Code 2R3332-5 , Lot Number 160830044M , Exp. Date 6/21/2016 17 Service Code 2R3332-5 , Lot Number 160970032M , Exp. Date 7/5/2016 18 Service Code 3332NO , Lot Number 160380115M , Exp. Date 5/7/2016 19 Service Code 3332NO , Lot Number 160420112M , Exp. Date 5/11/2016 20 Service Code 3332NO , Lot Number 160540138M , Exp. Date 5/24/2016 - Amount recalled
- 866 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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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