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FDAMay 5, 2016drug

1 mcg/mL Fentanyl Citrate and 0.08% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Yellow Smiths Medical Cassettes, Service Code 2T8175 Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-175-48

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.

What to do

FDA enforcement status: Terminated

Brands named

pharmedium servicespharmedium

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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