FDA-Drug2016-07-27Class II
4 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride 50 mL in 60 mL Monoject Syringe, Service Code 2K8983, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-983-48
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
3,828 syringes
Manufactured in
150 N Field Dr Ste 350, N/A, Lake Forest, IL, United States
Products
4 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride 50 mL in 60 mL Monoject Syringe, Service Code 2K8983, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-983-48
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1419-2016Don't want to check this manually?
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