FDA-Drug2016-07-27Class II

3 mcg/mL Fentanyl Citrate and 0.01% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K9217, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-217-97

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
700 bags
Manufactured in
150 N Field Dr Ste 350, N/A, Lake Forest, IL, United States
Products
3 mcg/mL Fentanyl Citrate and 0.01% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K9217, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-217-97

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1413-2016

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