FDA-Drug2016-07-27Class II
2.5 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 200 mL in 250 mL Baxter Intravia Bag, Service Code K8255 (NDC 61553-255-37), 200 ml in 250 ml Baxter Intravia Bag ; Service Code 2K8464 (NDC 61553-464-61), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141
Pharmedium Services, LLC
Hazard
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Sold states
Nationwide
Affected count
2,006 bags
Manufactured in
150 N Field Dr Ste 350, N/A, Lake Forest, IL, United States
Products
2.5 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 200 mL in 250 mL Baxter Intravia Bag, Service Code K8255 (NDC 61553-255-37), 200 ml in 250 ml Baxter Intravia Bag ; Service Code 2K8464 (NDC 61553-464-61), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1405-2016Don't want to check this manually?
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