Reported Jul 27, 2016 · Terminated
1 mcg/mL Fentanyl Citrate and 0.08% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 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?
- 1 mcg/mL Fentanyl Citrate and 0.08% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Yellow Smiths Medical Cassettes, Service Code 2T8175 Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-175-48
- Lot codes and dates
6 of 6 products
Products covered by this recall # Product as published 1 Lot Number 160630037M , Exp. Date 5/23/2016 2 Lot Number 160640007M , Exp. Date 5/24/2016 3 Lot Number 160700207M , Exp. Date 5/31/2016 4 Lot Number 160730149M , Exp. Date 6/3/2016 5 Lot Number 160830163M , Exp. Date 6/12/2016 6 Lot Number 160880258M , Exp. Date 6/18/2016 - Amount recalled
- 40 Medical Cassettes
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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