FDA-Drug2016-07-27Class II
2.5 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Yellow Smiths Medical Cassette, Service Code 2K8892, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-882-48
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
85 Medical Cassettes
Manufactured in
150 N Field Dr Ste 350, N/A, Lake Forest, IL, United States
Products
2.5 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Yellow Smiths Medical Cassette, Service Code 2K8892, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-882-48
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1404-2016Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief