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FDAMay 5, 2016drug

5 mcg/mL HYDROmorphone HCl and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 ml Hospira LifeCare Bag, Service Code 2H8477 (NDC 61553-477-50), 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8477 (NDC 61553-477-61), Rx Only, Compounded by PharMEDium Service...

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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