FDA-Drug2016-07-27Class II
1.5 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; Service Code 2T8232, (NDC 61553-232-97)250 ml in 250 ml Yellow Smiths Medical Cassette, flow stop free-flow protection Service Code 2T8878 100 ml in 100 ml Yellow Smiths Medical Cassette, flow stop free-flow protection ((NDC 61553-878-52), 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
384 Medical Cassettes
Manufactured in
150 N Field Dr Ste 350, N/A, Lake Forest, IL, United States
Products
1.5 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; Service Code 2T8232, (NDC 61553-232-97)250 ml in 250 ml Yellow Smiths Medical Cassette, flow stop free-flow protection Service Code 2T8878 100 ml in 100 ml Yellow Smiths Medical Cassette, flow stop free-flow protection ((NDC 61553-878-52), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1377-2016Don't want to check this manually?
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